An interventional study of Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter in Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation and Paroxysmal Atrial Fibrillation, sponsored by Biosense Webster, Inc.. Completed at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by Biosense Webster, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Other
The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 40 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Biosense Webster, Inc. is the lead sponsor of 64 studies on the registry; 8 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 24 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with cardiac arrhythmias/ablation history who are scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures will be using multi-electrode mapping catheter.
Device: Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
Participants scheduled to have a clinically-indicated catheter mapping and ablation procedure using globe-shaped, high-density, multi-electrode mapping catheter for management of atrial procedure (scar-related atrial tachycardia, persistent atrial fibrillation, paroxysmal atrial fibrillation) and Ventricular procedures (ventricular tachycardia, premature ventricular complex).
Number of Participants With Pre-ablation Mapping Requirements and Clinically Indicated Mapping Performed With the Investigational Catheter Without Resort to Non-study Mapping Catheter(s)
Number of participants with pre-ablation mapping requirements and clinically indicated mapping performed with the investigational catheter without resort to non-study mapping catheter(s) were reported.
Time frame: Up to 7 days of index procedure on Day 1
Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter
Number of participants with SAEs within 7 days of index procedure related to the investigational catheter were reported. An adverse event (AE) is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to 7 days of index procedure on Day 1
Number of Responders for Physician Assessment for Maneuverability and Handling
Number of responders for physician assessment for maneuverability \& handling were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for maneuverability and handling.
Time frame: Up to 29 weeks
Number of Responders for Physician Assessment for Signal Collection and Quality
Number of responders for physician assessment for signal collection and quality (UNIPOLAR signals in atria/ventricles, UNIPOLAR noise encountered, BIPOLAR signals in atria/ventricles, BASELINE noise encountered, and BIPOLAR noise encountered) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for signal collection and quality.
Time frame: Up to 29 weeks
Number of Responders for Physician Assessment for Pacing
Number of responders for physician assessment for pacing (high output stimulation pacing and local pacing capture) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for pacing.
Time frame: Up to 29 weeks
Number of Responders for Physician Assessment for Catheter Design
Number of responders for physician assessment for catheter design were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter design.
Time frame: Up to 29 weeks
Number of Responders for Physician Assessment for Workflow
Number of responders for physician assessment for workflow were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for workflow.
Time frame: Up to 29 weeks
Number of Responders for Physician Assessment for Catheter Visualization
Number of responders for physician assessment for catheter visualization were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter visualization.
Time frame: Up to 29 weeks
Number of Responders for Physician Assessment for Catheters Interactions
Number of responders for physician assessment for catheters interactions were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheters interactions.
Time frame: Up to 29 weeks
Number of Responders for Physician Assessment for Arrhythmogenicity
Number of responders for physician assessment for arrhythmogenicity were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for arrhythmogenicity.
Time frame: Up to 29 weeks
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Number of responders for physician assessment for design and coverage for confirming PVI were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for design and coverage for confirming PVI.
Time frame: Up to 29 weeks
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Number of responders for physician assessment for ability to characterize the tissue were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for ability to characterize the tissue.
Time frame: Up to 29 weeks
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Number of responders for physician assessment for ability to identify arrhythmia circuit or source correctly were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for ability to identify arrhythmia circuit or source correctly.
Time frame: Up to 29 weeks
Number of Participants With SAEs Excluding Investigational Catheter Related Within 7 Days of Index Procedure
Number of participants with SAEs excluding investigational catheter related within 7 days of index procedure were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to 7 days of index procedure on Day 1
Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the Investigational Catheter
Number of participants with non-serious AEs within 7 days of index procedure related to the investigational catheter were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device.
Time frame: Up to 7 days of index procedure on Day 1
| Milestone | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Started | 40 |
| Completed | 40 |
| Not completed | 0 |
Number of participants with pre-ablation mapping requirements and clinically indicated mapping performed with the investigational catheter without resort to non-study mapping catheter(s) were reported.
| Participants | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Number of Participants With Pre-ablation Mapping Requirements and Clinically Indicated Mapping Performed With the Investigational Catheter Without Resort to Non-study Mapping Catheter(s) | 40 |
Number of participants with SAEs within 7 days of index procedure related to the investigational catheter were reported. An adverse event (AE) is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
| Participants | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter | 1 |
Number of responders for physician assessment for maneuverability \& handling were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for maneuverability and handling.
| Participants | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Ability to Deploy (Left Atrium): Score 1 | 0 |
| Ability to Deploy (Left Atrium): Score 2 | 1 |
| Ability to Deploy (Left Atrium): Score 3 | 1 |
| Ability to Deploy (Left Atrium): Score 4 | 6 |
| Ability to Deploy (Left Atrium): Score 5 | 7 |
| Ability to Deploy (Left Atrium): Score 6 | 14 |
| Ability to Deploy (Left Atrium): Score 7 | 3 |
| Ability to Deploy (Right Atrium): Score 1 | 0 |
| Ability to Deploy (Right Atrium): Score 2 | 0 |
| Ability to Deploy (Right Atrium): Score 3 | 1 |
| Ability to Deploy (Right Atrium): Score 4 | 4 |
| Ability to Deploy (Right Atrium): Score 5 | 4 |
| Ability to Deploy (Right Atrium): Score 6 | 9 |
| Ability to Deploy (Right Atrium): Score 7 | 2 |
| Ability to Deploy (Left Ventricle): Score 1 | 0 |
| Ability to Deploy (Left Ventricle): Score 2 | 0 |
| Ability to Deploy (Left Ventricle): Score 3 | 0 |
| Ability to Deploy (Left Ventricle): Score 4 | 0 |
| Ability to Deploy (Left Ventricle): Score 5 | 0 |
| Ability to Deploy (Left Ventricle): Score 6 | 1 |
| Ability to Deploy (Left Ventricle): Score 7 | 1 |
| Ability to Deploy (Right Ventricle): Score 1 | 0 |
| Ability to Deploy (Right Ventricle): Score 2 | 0 |
| Ability to Deploy (Right Ventricle): Score 3 | 0 |
| Ability to Deploy (Right Ventricle): Score 4 | 2 |
| Ability to Deploy (Right Ventricle): Score 5 | 2 |
| Ability to Deploy (Right Ventricle): Score 6 | 4 |
| Ability to Deploy (Right Ventricle): Score 7 | 0 |
| Ability to Maneuver (Left Atrium): Score 1 | 0 |
| Ability to Maneuver (Left Atrium): Score 2 | 1 |
| Ability to Maneuver (Left Atrium): Score 3 | 0 |
| Ability to Maneuver (Left Atrium): Score 4 | 4 |
| Ability to Maneuver (Left Atrium): Score 5 | 8 |
| Ability to Maneuver (Left Atrium): Score 6 | 10 |
| Ability to Maneuver (Left Atrium): Score 7 | 9 |
| Ability to Maneuver (Right Atrium): Score 1 | 0 |
| Ability to Maneuver (Right Atrium): Score 2 | 0 |
| Ability to Maneuver (Right Atrium): Score 3 | 0 |
| Ability to Maneuver (Right Atrium): Score 4 | 1 |
| Ability to Maneuver (Right Atrium): Score 5 | 7 |
| Ability to Maneuver (Right Atrium): Score 6 | 7 |
| Ability to Maneuver (Right Atrium): Score 7 | 2 |
| Ability to Maneuver (Left Ventricle): Score 1 | 0 |
| Ability to Maneuver (Left Ventricle): Score 2 | 0 |
| Ability to Maneuver (Left Ventricle): Score 3 | 0 |
| Ability to Maneuver (Left Ventricle): Score 4 | 1 |
| Ability to Maneuver (Left Ventricle): Score 5 | 0 |
| Ability to Maneuver (Left Ventricle): Score 6 | 0 |
| Ability to Maneuver (Left Ventricle): Score 7 | 1 |
| Ability to Maneuver (Right Ventricle): Score 1 | 0 |
| Ability to Maneuver (Right Ventricle): Score 2 | 0 |
| Ability to Maneuver (Right Ventricle): Score 3 | 0 |
| Ability to Maneuver (Right Ventricle): Score 4 | 2 |
| Ability to Maneuver (Right Ventricle): Score 5 | 2 |
| Ability to Maneuver (Right Ventricle): Score 6 | 3 |
| Ability to Maneuver (Right Ventricle): Score 7 | 1 |
| Ability to Reach Areas (Left Atrium): Score 1 | 0 |
| Ability to Reach Areas (Left Atrium): Score 2 | 1 |
| Ability to Reach Areas (Left Atrium): Score 3 | 0 |
| Ability to Reach Areas (Left Atrium): Score 4 | 4 |
| Ability to Reach Areas (Left Atrium): Score 5 | 7 |
| Ability to Reach Areas (Left Atrium): Score 6 | 11 |
| Ability to Reach Areas (Left Atrium): Score 7 | 8 |
| Ability to Reach Areas (Right Atrium): Score 1 | 0 |
| Ability to Reach Areas (Right Atrium): Score 2 | 0 |
| Ability to Reach Areas (Right Atrium): Score 3 | 0 |
| Ability to Reach Areas (Right Atrium): Score 4 | 2 |
| Ability to Reach Areas (Right Atrium): Score 5 | 5 |
| Ability to Reach Areas (Right Atrium): Score 6 | 8 |
| Ability to Reach Areas (Right Atrium): Score 7 | 2 |
| Ability to Reach Areas (Left Ventricle): Score 1 | 0 |
| Ability to Reach Areas (Left Ventricle): Score 2 | 0 |
| Ability to Reach Areas (Left Ventricle): Score 3 | 0 |
| Ability to Reach Areas (Left Ventricle): Score 4 | 1 |
| Ability to Reach Areas (Left Ventricle): Score 5 | 0 |
| Ability to Reach Areas (Left Ventricle): Score 6 | 0 |
| Ability to Reach Areas (Left Ventricle): Score 7 | 1 |
| Ability to Reach Areas (Right Ventricle): Score 1 | 0 |
| Ability to Reach Areas (Right Ventricle): Score 2 | 0 |
| Ability to Reach Areas (Right Ventricle): Score 3 | 0 |
| Ability to Reach Areas (Right Ventricle): Score 4 | 2 |
| Ability to Reach Areas (Right Ventricle): Score 5 | 3 |
| Ability to Reach Areas (Right Ventricle): Score 6 | 3 |
| Ability to Reach Areas (Right Ventricle): Score 7 | 0 |
| Ability to withdraw (Left Atrium): Score 1 | 0 |
| Ability to withdraw (Left Atrium): Score 2 | 0 |
| Ability to withdraw (Left Atrium): Score 3 | 1 |
| Ability to withdraw (Left Atrium): Score 4 | 6 |
| Ability to withdraw (Left Atrium): Score 5 | 5 |
| Ability to withdraw (Left Atrium): Score 6 | 10 |
| Ability to withdraw (Left Atrium): Score 7 | 10 |
| Ability to withdraw (Right Atrium): Score 1 | 0 |
| Ability to withdraw (Right Atrium): Score 2 | 0 |
| Ability to withdraw (Right Atrium): Score 3 | 0 |
| Ability to withdraw (Right Atrium): Score 4 | 4 |
| Ability to withdraw (Right Atrium): Score 5 | 3 |
| Ability to withdraw (Right Atrium): Score 6 | 9 |
| Ability to withdraw (Right Atrium): Score 7 | 3 |
| Ability to withdraw (Left Ventricles): Score 1 | 0 |
| Ability to withdraw (Left Ventricles): Score 2 | 0 |
| Ability to withdraw (Left Ventricles): Score 3 | 0 |
| Ability to withdraw (Left Ventricles): Score 4 | 0 |
| Ability to withdraw (Left Ventricles): Score 5 | 0 |
| Ability to withdraw (Left Ventricles): Score 6 | 1 |
| Ability to withdraw (Left Ventricles): Score 7 | 1 |
| Ability to withdraw (Right Ventricles): Score 1 | 0 |
| Ability to withdraw (Right Ventricles): Score 2 | 0 |
| Ability to withdraw (Right Ventricles): Score 3 | 0 |
| Ability to withdraw (Right Ventricles): Score 4 | 1 |
| Ability to withdraw (Right Ventricles): Score 5 | 2 |
| Ability to withdraw (Right Ventricles): Score 6 | 4 |
| Ability to withdraw (Right Ventricles): Score 7 | 1 |
| Overall ease of use of the catheter: Score 1 | 0 |
| Overall ease of use of the catheter: Score 2 | 1 |
| Overall ease of use of the catheter: Score 3 | 0 |
| Overall ease of use of the catheter: Score 4 | 6 |
| Overall ease of use of the catheter: Score 5 | 11 |
| Overall ease of use of the catheter: Score 6 | 20 |
| Overall ease of use of the catheter: Score 7 | 2 |
| Insertion and withdrawal from introducer sheath: Score 1 | 0 |
| Insertion and withdrawal from introducer sheath: Score 2 | 1 |
| Insertion and withdrawal from introducer sheath: Score 3 | 0 |
| Insertion and withdrawal from introducer sheath: Score 4 | 4 |
| Insertion and withdrawal from introducer sheath: Score 5 | 10 |
| Insertion and withdrawal from introducer sheath: Score 6 | 13 |
| Insertion and withdrawal from introducer sheath: Score 7 | 12 |
| Learning curve: Score 1 | 0 |
| Learning curve: Score 2 | 1 |
| Learning curve: Score 3 | 0 |
| Learning curve: Score 4 | 6 |
| Learning curve: Score 5 | 12 |
| Learning curve: Score 6 | 17 |
| Learning curve: Score 7 | 4 |
Number of responders for physician assessment for signal collection and quality (UNIPOLAR signals in atria/ventricles, UNIPOLAR noise encountered, BIPOLAR signals in atria/ventricles, BASELINE noise encountered, and BIPOLAR noise encountered) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for signal collection and quality.
| Participants | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| UNIPOLAR signals in Atria: Score 1 | 0 |
| UNIPOLAR signals in Atria: Score 2 | 0 |
| UNIPOLAR signals in Atria: Score 3 | 0 |
| UNIPOLAR signals in Atria: Score 4 | 3 |
| UNIPOLAR signals in Atria: Score 5 | 5 |
| UNIPOLAR signals in Atria: Score 6 | 5 |
| UNIPOLAR signals in Atria: Score 7 | 6 |
| UNIPOLAR signals in Ventricles: Score 1 | 0 |
| UNIPOLAR signals in Ventricles: Score 2 | 0 |
| UNIPOLAR signals in Ventricles: Score 3 | 0 |
| UNIPOLAR signals in Ventricles: Score 4 | 2 |
| UNIPOLAR signals in Ventricles: Score 5 | 1 |
| UNIPOLAR signals in Ventricles: Score 6 | 2 |
| UNIPOLAR signals in Ventricles: Score 7 | 4 |
| UNIPOLAR noise encountered: Score 1 | 0 |
| UNIPOLAR noise encountered: Score 2 | 0 |
| UNIPOLAR noise encountered: Score 3 | 0 |
| UNIPOLAR noise encountered: Score 4 | 5 |
| UNIPOLAR noise encountered: Score 5 | 6 |
| UNIPOLAR noise encountered: Score 6 | 11 |
| UNIPOLAR noise encountered: Score 7 | 6 |
| BIPOLAR signals in Atria: Score 1 | 0 |
| BIPOLAR signals in Atria: Score 2 | 0 |
| BIPOLAR signals in Atria: Score 3 | 0 |
| BIPOLAR signals in Atria: Score 4 | 4 |
| BIPOLAR signals in Atria: Score 5 | 6 |
| BIPOLAR signals in Atria: Score 6 | 7 |
| BIPOLAR signals in Atria: Score 7 | 15 |
| BIPOLAR signals in Ventricles: Score 1 | 0 |
| BIPOLAR signals in Ventricles: Score 2 | 0 |
| BIPOLAR signals in Ventricles: Score 3 | 0 |
| BIPOLAR signals in Ventricles: Score 4 | 1 |
| BIPOLAR signals in Ventricles: Score 5 | 0 |
| BIPOLAR signals in Ventricles: Score 6 | 2 |
| BIPOLAR signals in Ventricles: Score 7 | 7 |
| BASELINE noise encountered: Score 1 | 0 |
| BASELINE noise encountered: Score 2 | 0 |
| BASELINE noise encountered: Score 3 | 0 |
| BASELINE noise encountered: Score 4 | 5 |
| BASELINE noise encountered: Score 5 | 7 |
| BASELINE noise encountered: Score 6 | 12 |
| BASELINE noise encountered: Score 7 | 14 |
| BIPOLAR noise encountered: Score 1 | 0 |
| BIPOLAR noise encountered: Score 2 | 0 |
| BIPOLAR noise encountered: Score 3 | 0 |
| BIPOLAR noise encountered: Score 4 | 5 |
| BIPOLAR noise encountered: Score 5 | 9 |
| BIPOLAR noise encountered: Score 6 | 9 |
| BIPOLAR noise encountered: Score 7 | 15 |
Number of responders for physician assessment for pacing (high output stimulation pacing and local pacing capture) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for pacing.
| Participants | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| High output stimulation pacing: Score 1 | 0 |
| High output stimulation pacing: Score 2 | 0 |
| High output stimulation pacing: Score 3 | 0 |
| High output stimulation pacing: Score 4 | 1 |
| High output stimulation pacing: Score 5 | 1 |
| High output stimulation pacing: Score 6 | 1 |
| High output stimulation pacing: Score 7 | 2 |
| Local pacing capture: Score 1 | 0 |
| Local pacing capture: Score 2 | 1 |
| Local pacing capture: Score 3 | 2 |
| Local pacing capture: Score 4 | 4 |
| Local pacing capture: Score 5 | 7 |
| Local pacing capture: Score 6 | 4 |
| Local pacing capture: Score 7 | 5 |
Number of responders for physician assessment for catheter design were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter design.
| Participants | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Ability to achieve electrode contact with cardiac tissue: Score 1 | 0 |
| Ability to achieve electrode contact with cardiac tissue: Score 2 | 1 |
| Ability to achieve electrode contact with cardiac tissue: Score 3 | 0 |
| Ability to achieve electrode contact with cardiac tissue: Score 4 | 4 |
| Ability to achieve electrode contact with cardiac tissue: Score 5 | 11 |
| Ability to achieve electrode contact with cardiac tissue: Score 6 | 22 |
| Ability to achieve electrode contact with cardiac tissue: Score 7 | 2 |
| Electrodes spacing: Score 1 | 0 |
| Electrodes spacing: Score 2 | 0 |
| Electrodes spacing: Score 3 | 0 |
| Electrodes spacing: Score 4 | 4 |
| Electrodes spacing: Score 5 | 10 |
| Electrodes spacing: Score 6 | 13 |
| Electrodes spacing: Score 7 | 13 |
| Electrode array coverage: Score 1 | 0 |
| Electrode array coverage: Score 2 | 0 |
| Electrode array coverage: Score 3 | 0 |
| Electrode array coverage: Score 4 | 4 |
| Electrode array coverage: Score 5 | 10 |
| Electrode array coverage: Score 6 | 18 |
| Electrode array coverage: Score 7 | 8 |
Number of responders for physician assessment for workflow were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for workflow.
| Participants | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Ability to reduce fluoroscopy: Score 1 | 0 |
| Ability to reduce fluoroscopy: Score 2 | 1 |
| Ability to reduce fluoroscopy: Score 3 | 4 |
| Ability to reduce fluoroscopy: Score 4 | 5 |
| Ability to reduce fluoroscopy: Score 5 | 14 |
| Ability to reduce fluoroscopy: Score 6 | 4 |
| Ability to reduce fluoroscopy: Score 7 | 10 |
| Time for pre-procedure mapping: Score 1 | 0 |
| Time for pre-procedure mapping: Score 2 | 1 |
| Time for pre-procedure mapping: Score 3 | 0 |
| Time for pre-procedure mapping: Score 4 | 4 |
| Time for pre-procedure mapping: Score 5 | 14 |
| Time for pre-procedure mapping: Score 6 | 19 |
| Time for pre-procedure mapping: Score 7 | 2 |
| Time for post-procedure mapping after standard of care ablation: Score 1 | 0 |
| Time for post-procedure mapping after standard of care ablation: Score 2 | 1 |
| Time for post-procedure mapping after standard of care ablation: Score 3 | 0 |
| Time for post-procedure mapping after standard of care ablation: Score 4 | 4 |
| Time for post-procedure mapping after standard of care ablation: Score 5 | 8 |
| Time for post-procedure mapping after standard of care ablation: Score 6 | 11 |
| Time for post-procedure mapping after standard of care ablation: Score 7 | 12 |
| Ability to identify targets: Score 1 | 0 |
| Ability to identify targets: Score 2 | 0 |
| Ability to identify targets: Score 3 | 0 |
| Ability to identify targets: Score 4 | 4 |
| Ability to identify targets: Score 5 | 11 |
| Ability to identify targets: Score 6 | 9 |
| Ability to identify targets: Score 7 | 5 |
Number of responders for physician assessment for catheter visualization were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter visualization.
| Participants | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Visualization under fluoroscopy: Score 1 | 0 |
| Visualization under fluoroscopy: Score 2 | 2 |
| Visualization under fluoroscopy: Score 3 | 0 |
| Visualization under fluoroscopy: Score 4 | 5 |
| Visualization under fluoroscopy: Score 5 | 10 |
| Visualization under fluoroscopy: Score 6 | 18 |
| Visualization under fluoroscopy: Score 7 | 3 |
| Visualization in CARTO 3: Score 1 | 0 |
| Visualization in CARTO 3: Score 2 | 0 |
| Visualization in CARTO 3: Score 3 | 4 |
| Visualization in CARTO 3: Score 4 | 6 |
| Visualization in CARTO 3: Score 5 | 9 |
| Visualization in CARTO 3: Score 6 | 9 |
| Visualization in CARTO 3: Score 7 | 12 |
Number of responders for physician assessment for catheters interactions were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheters interactions.
| Participants | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| CARTO 3 System: Score 1 | 1 |
| CARTO 3 System: Score 2 | 0 |
| CARTO 3 System: Score 3 | 2 |
| CARTO 3 System: Score 4 | 7 |
| CARTO 3 System: Score 5 | 10 |
| CARTO 3 System: Score 6 | 16 |
| CARTO 3 System: Score 7 | 4 |
| Electrophysiology (EP) Lab recording equipment: Score 1 | 1 |
| EP Lab recording equipment: Score 2 | 0 |
| EP Lab recording equipment: Score 3 | 2 |
| EP Lab recording equipment: Score 4 | 6 |
| EP Lab recording equipment: Score 5 | 16 |
| EP Lab recording equipment: Score 6 | 11 |
| EP Lab recording equipment: Score 7 | 4 |
| Pacing equipment: Score 1 | 0 |
| Pacing equipment: Score 2 | 0 |
| Pacing equipment: Score 3 | 0 |
| Pacing equipment: Score 4 | 4 |
| Pacing equipment: Score 5 | 12 |
| Pacing equipment: Score 6 | 3 |
| Pacing equipment: Score 7 | 8 |
| Introducer tool on catheter: Score 1 | 1 |
| Introducer tool on catheter: Score 2 | 1 |
| Introducer tool on catheter: Score 3 | 0 |
| Introducer tool on catheter: Score 4 | 5 |
| Introducer tool on catheter: Score 5 | 8 |
| Introducer tool on catheter: Score 6 | 13 |
| Introducer tool on catheter: Score 7 | 12 |
| Sheath: Score 1 | 1 |
| Sheath: Score 2 | 1 |
| Sheath: Score 3 | 0 |
| Sheath: Score 4 | 5 |
| Sheath: Score 5 | 9 |
| Sheath: Score 6 | 12 |
| Sheath: Score 7 | 12 |
| Irrigation bag and tubing: Score 1 | 1 |
| Irrigation bag and tubing: Score 2 | 0 |
| Irrigation bag and tubing: Score 3 | 0 |
| Irrigation bag and tubing: Score 4 | 6 |
| Irrigation bag and tubing: Score 5 | 9 |
| Irrigation bag and tubing: Score 6 | 12 |
| Irrigation bag and tubing: Score 7 | 12 |
| Implantable cardioverter-defibrillators (ICD) or other implantable devices: Score 1 | 0 |
| ICD or other implantable devices: Score 2 | 0 |
| ICD or other implantable devices: Score 3 | 0 |
| ICD or other implantable devices: Score 4 | 0 |
| ICD or other implantable devices: Score 5 | 0 |
| ICD or other implantable devices: Score 6 | 1 |
| ICD or other implantable devices: Score 7 | 0 |
Number of responders for physician assessment for arrhythmogenicity were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for arrhythmogenicity.
| Participants | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Compared to the PENTARAY catheter: Score 1 | 0 |
| Compared to the PENTARAY catheter: Score 2 | 0 |
| Compared to the PENTARAY catheter: Score 3 | 1 |
| Compared to the PENTARAY catheter: Score 4 | 1 |
| Compared to the PENTARAY catheter: Score 5 | 10 |
| Compared to the PENTARAY catheter: Score 6 | 20 |
| Compared to the PENTARAY catheter: Score 7 | 8 |
| Compared to other competitive multielectrode catheters: Score 1 | 0 |
| Compared to other competitive multielectrode catheters: Score 2 | 0 |
| Compared to other competitive multielectrode catheters: Score 3 | 1 |
| Compared to other competitive multielectrode catheters: Score 4 | 5 |
| Compared to other competitive multielectrode catheters: Score 5 | 7 |
| Compared to other competitive multielectrode catheters: Score 6 | 12 |
| Compared to other competitive multielectrode catheters: Score 7 | 4 |
Number of responders for physician assessment for design and coverage for confirming PVI were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for design and coverage for confirming PVI.
| Participants | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Compared to the PENTARAY catheter: Score 1 | 0 |
| Compared to the PENTARAY catheter: Score 2 | 0 |
| Compared to the PENTARAY catheter: Score 3 | 1 |
| Compared to the PENTARAY catheter: Score 4 | 1 |
| Compared to the PENTARAY catheter: Score 5 | 8 |
| Compared to the PENTARAY catheter: Score 6 | 12 |
| Compared to the PENTARAY catheter: Score 7 | 8 |
| Compared to other competitive multielectrode catheters: Score 1 | 0 |
| Compared to other competitive multielectrode catheters: Score 2 | 0 |
| Compared to other competitive multielectrode catheters: Score 3 | 1 |
| Compared to other competitive multielectrode catheters: Score 4 | 1 |
| Compared to other competitive multielectrode catheters: Score 5 | 10 |
| Compared to other competitive multielectrode catheters: Score 6 | 6 |
| Compared to other competitive multielectrode catheters: Score 7 | 3 |
Number of responders for physician assessment for ability to characterize the tissue were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for ability to characterize the tissue.
| Participants | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Compared to the PENTARAY catheter: Score 1 | 0 |
| Compared to the PENTARAY catheter: Score 2 | 0 |
| Compared to the PENTARAY catheter: Score 3 | 1 |
| Compared to the PENTARAY catheter: Score 4 | 5 |
| Compared to the PENTARAY catheter: Score 5 | 10 |
| Compared to the PENTARAY catheter: Score 6 | 17 |
| Compared to the PENTARAY catheter: Score 7 | 7 |
| Compared to other competitive multielectrode catheters: Score 1 | 0 |
| Compared to other competitive multielectrode catheters: Score 2 | 0 |
| Compared to other competitive multielectrode catheters: Score 3 | 0 |
| Compared to other competitive multielectrode catheters: Score 4 | 8 |
| Compared to other competitive multielectrode catheters: Score 5 | 9 |
| Compared to other competitive multielectrode catheters: Score 6 | 10 |
| Compared to other competitive multielectrode catheters: Score 7 | 1 |
Number of responders for physician assessment for ability to identify arrhythmia circuit or source correctly were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for ability to identify arrhythmia circuit or source correctly.
| Participants | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Compared to the PENTARAY catheter: Score 1 | 0 |
| Compared to the PENTARAY catheter: Score 2 | 1 |
| Compared to the PENTARAY catheter: Score 3 | 0 |
| Compared to the PENTARAY catheter: Score 4 | 3 |
| Compared to the PENTARAY catheter: Score 5 | 14 |
| Compared to the PENTARAY catheter: Score 6 | 18 |
| Compared to the PENTARAY catheter: Score 7 | 4 |
| Compared to other competitive multielectrode catheters: Score 1 | 0 |
| Compared to other competitive multielectrode catheters: Score 2 | 0 |
| Compared to other competitive multielectrode catheters: Score 3 | 1 |
| Compared to other competitive multielectrode catheters: Score 4 | 5 |
| Compared to other competitive multielectrode catheters: Score 5 | 14 |
| Compared to other competitive multielectrode catheters: Score 6 | 7 |
| Compared to other competitive multielectrode catheters: Score 7 | 1 |
Number of participants with SAEs excluding investigational catheter related within 7 days of index procedure were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
| Participants | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Number of Participants With SAEs Excluding Investigational Catheter Related Within 7 Days of Index Procedure | 3 |
Number of participants with non-serious AEs within 7 days of index procedure related to the investigational catheter were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device.
| Participants | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the Investigational Catheter | 1 |
Collected over From screening up to 29 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) | 0/40 (0%) | 4/40 (10%) | 1/40 (2.5%) |
| Event | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Atrioventricular blockCardiac disorders | 1/40 |
| Cardiac tamponadeCardiac disorders | 1/40 |
| Pericardial effusionCardiac disorders | 1/40 |
| Transient complete atrioventricular blockCardiac disorders | 1/40 |
| Event | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Transient right bundle branch blockCardiac disorders | 1/40 |
| Age, Continuous(years) | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Mean | 58.0 ± 15.73 |
| Sex: Female, Male(Participants) | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|---|
| Female | 15 |
| Male | 25 |
| Race and Ethnicity Not Collected(Participants) | Multi-electrode Electrocardiogram (ECG) Mapping Catheter (Investigational Catheter) |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Data sharing details ↗ · yoda.yale.edu
Ran from Jul 2022 to primary completion in Feb 2023, 6 months.
Results were first posted in Mar 2024, 1 year after primary completion.
Of 255 industry-sponsored interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's 6 months is below that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.