An interventional study of OPTRELL Mapping Catheter in Scar-related Atrial Tachycardia, Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, sponsored by Biosense Webster, Inc.. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Biosense Webster, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Other
Among 52 studies in Atrial Fibrillation by Biosense Webster, Inc. — 6 open to participants now, 10 under way, none of them phase 3. Atrial Fibrillation · Biosense Webster, Inc..
Among the 52 studies in Atrial Fibrillation by Biosense Webster, Inc., this one is the 42nd largest by enrollment of the 47 interventional ones, is the only one that started in 2021, is one of 30 with no phase, and was the 34th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 31 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →6 of the 52 studies in Atrial Fibrillation by Biosense Webster, Inc. are open now, in 5 countries. Each count lists the studies.
Of the 612 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 44 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →52 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2021.
Median enrollment 149 across the 47 interventional studies, 234 across the 5 observational. Of the 41 that completed or were terminated, 32 (78%) have results posted.
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.
5 of the studies in Atrial Fibrillation by Biosense Webster, Inc. that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07429214Biosense Webster, Inc.A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF | 2026-12-30 |
| NCT07428564Biosense Webster, Inc.A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF | 2026-12-30 |
| NCT03963349Biosense Webster, Inc.THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study | 2026-12-31 |
| NCT07116525Biosense Webster, Inc.A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter | 2027-02-07 |
| NCT06455098Biosense Webster, Inc.A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF) | 2027-07-31 |
Among the 52 studies in Atrial Fibrillation by Biosense Webster, Inc., from their registry updates:
The purpose of this study is to assess the performance and safety for the use of the OPTRELL Catheter for intracardiac mapping in the atria and ventricles.
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 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.
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.
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.
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.
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.
Participants diagnosed with cardiac arrhythmias 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 OPTRELL mapping catheter.
Device: OPTRELL Mapping Catheter
Participants scheduled to have a clinically-indicated catheter mapping and ablation using OPTRELL mapping catheter for the 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 Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the OPTRELL Catheter
Number of participants with SAEs within 7 days of index procedure related to the OPTRELL 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 at Day 0
Number of Participants With Pre-ablation Mapping and Clinically Indicated Mapping Performed With the OPTRELL Catheter Without Resort to Other Mapping Catheters
Number of participants with pre-ablation mapping and clinically indicated mapping performed with the OPTRELL catheter without resort to other mapping catheters were reported.
Time frame: Up to 72 days
Number of Participants With SAEs Within 7 Days of Index Procedure
Number of participants with SAEs 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 at Day 0
Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Associated With the Use of the OPTRELL Catheter
Number of participants with non-serious adverse events within 7 days of index procedure associated with the use of the OPTRELL catheter were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: Up to 7 days of index procedure at Day 0
Number of Responders for Physician Assessment for Maneuverability & 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 \& handling.
Time frame: Up to 72 days
Number of Responders for Physician Assessment for Signal Collection and Quality
Number of responders for physician assessment for signal collection and quality 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 72 days
Number of Responders for Physician Assessment for Pacing
Number of responders for physician assessment for pacing (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 72 days
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
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 in OPTRELL catheter for mapping.
Time frame: Up to 72 days
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 72 days
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 72 days
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 72 days
Number of Responders for Physician Assessment for Arrhythmogenicity
Number of responders with 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 72 days
Number of Responders for Physician Assessment for Design and Coverage for Confirming 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 72 days
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 72 days
| Milestone | OPTRELL Mapping Catheter |
|---|---|
| Started | 31 |
| Completed | 31 |
| Not completed | 0 |
Number of participants with SAEs within 7 days of index procedure related to the OPTRELL 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 | OPTRELL Mapping Catheter |
|---|---|
| Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the OPTRELL Catheter | 0 |
Number of participants with pre-ablation mapping and clinically indicated mapping performed with the OPTRELL catheter without resort to other mapping catheters were reported.
| Participants | OPTRELL Mapping Catheter |
|---|---|
| Number of Participants With Pre-ablation Mapping and Clinically Indicated Mapping Performed With the OPTRELL Catheter Without Resort to Other Mapping Catheters | 31 |
Number of participants with SAEs 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 | OPTRELL Mapping Catheter |
|---|---|
| Number of Participants With SAEs Within 7 Days of Index Procedure | 3 |
Number of participants with non-serious adverse events within 7 days of index procedure associated with the use of the OPTRELL catheter were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
| Participants | OPTRELL Mapping Catheter |
|---|---|
| Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Associated With the Use of the OPTRELL Catheter | 0 |
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 \& handling.
| Participants | OPTRELL Mapping Catheter |
|---|---|
| Ability to Deploy (Left Atrium): Score 1 | 0 |
| Ability to Deploy (Left Atrium): Score 2 | 0 |
| Ability to Deploy (Left Atrium): Score 3 | 0 |
| Ability to Deploy (Left Atrium): Score 4 | 0 |
| Ability to Deploy (Left Atrium): Score 5 | 0 |
| Ability to Deploy (Left Atrium): Score 6 | 6 |
| Ability to Deploy (Left Atrium): Score 7 | 17 |
| Ability to Deploy (Right Atrium): Score 1 | 0 |
| Ability to Deploy (Right Atrium): Score 2 | 0 |
| Ability to Deploy (Right Atrium): Score 3 | 0 |
| Ability to Deploy (Right Atrium): Score 4 | 0 |
| Ability to Deploy (Right Atrium): Score 5 | 0 |
| Ability to Deploy (Right Atrium): Score 6 | 3 |
| Ability to Deploy (Right Atrium): Score 7 | 3 |
| 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 | 3 |
| Ability to Deploy (Left Ventricle): Score 5 | 1 |
| Ability to Deploy (Left Ventricle): Score 6 | 5 |
| Ability to Deploy (Left Ventricle): Score 7 | 0 |
| 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 | 1 |
| Ability to Deploy (Right Ventricle): Score 5 | 0 |
| Ability to Deploy (Right Ventricle): Score 6 | 0 |
| Ability to Deploy (Right Ventricle): Score 7 | 0 |
| Ability to Maneuver (Left Atrium): Score 1 | 0 |
| Ability to Maneuver (Left Atrium): Score 2 | 0 |
| Ability to Maneuver (Left Atrium): Score 3 | 0 |
| Ability to Maneuver (Left Atrium): Score 4 | 0 |
| Ability to Maneuver (Left Atrium): Score 5 | 7 |
| Ability to Maneuver (Left Atrium): Score 6 | 7 |
| 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 | 0 |
| Ability to Maneuver (Right Atrium): Score 5 | 1 |
| Ability to Maneuver (Right Atrium): Score 6 | 1 |
| Ability to Maneuver (Right Atrium): Score 7 | 4 |
| 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 | 5 |
| Ability to Maneuver (Left Ventricle): Score 5 | 0 |
| Ability to Maneuver (Left Ventricle): Score 6 | 4 |
| Ability to Maneuver (Left Ventricle): Score 7 | 0 |
| Ability to Maneuver (Right Ventricle): Score 1 | 0 |
| Ability to Maneuver (Right Ventricle): Score 2 | 0 |
| Ability to Maneuver (Right Ventricle): Score 3 | 1 |
| Ability to Maneuver (Right Ventricle): Score 4 | 0 |
| Ability to Maneuver (Right Ventricles): Score 5 | 0 |
| Ability to Maneuver (Right Ventricle): Score 6 | 0 |
| Ability to Maneuver (Right Ventricle): Score 7 | 0 |
| Ability to Reach Areas (Left Atrium): Score 1 | 0 |
| Ability to Reach Areas (Left Atrium): Score 2 | 0 |
| Ability to Reach Areas (Left Atrium): Score 3 | 0 |
| Ability to Reach Areas (Left Atrium): Score 4 | 2 |
| Ability to Reach Areas (Left Atrium): Score 5 | 3 |
| Ability to Reach Areas (Left Atrium): Score 6 | 12 |
| Ability to Reach Areas (Left Atrium): Score 7 | 6 |
| 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 | 0 |
| Ability to Reach Areas (Right Atrium): Score 5 | 2 |
| Ability to Reach Areas (Right Atrium): Score 6 | 1 |
| Ability to Reach Areas (Right Atrium): Score 7 | 3 |
| 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 | 1 |
| Ability to Reach Areas (Left Ventricle): Score 4 | 3 |
| Ability to Reach Areas (Left Ventricle): Score 5 | 2 |
| Ability to Reach Areas (Left Ventricle): Score 6 | 3 |
| Ability to Reach Areas (Left Ventricle): Score 7 | 0 |
| 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 | 1 |
| Ability to Reach Areas (Right Ventricle): Score 5 | 0 |
| Ability to Reach Areas (Right Ventricle): Score 6 | 0 |
| 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 | 0 |
| Ability to Withdraw (Left Atrium): Score 4 | 0 |
| Ability to Withdraw (Left Atrium): Score 5 | 0 |
| Ability to Withdraw (Left Atrium): Score 6 | 8 |
| Ability to Withdraw (Left Atrium): Score 7 | 15 |
| 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 | 0 |
| Ability to Withdraw (Right Atrium): Score 5 | 0 |
| Ability to Withdraw (Right Atrium): Score 6 | 4 |
| Ability to Withdraw (Right Atrium): Score 7 | 2 |
| Ability to Withdraw (Left Ventricle): Score 1 | 0 |
| Ability to Withdraw (Left Ventricle): Score 2 | 0 |
| Ability to Withdraw (Left Ventricle): Score 3 | 0 |
| Ability to Withdraw (Left Ventricle): Score 4 | 2 |
| Ability to Withdraw (Left Ventricle): Score 5 | 2 |
| Ability to Withdraw (Left Ventricle): Score 6 | 5 |
| Ability to Withdraw (Left Ventricle): Score 7 | 0 |
| Ability to Withdraw (Right Ventricle): Score 1 | 0 |
| Ability to Withdraw (Right Ventricle): Score 2 | 0 |
| Ability to Withdraw (Right Ventricle): Score 3 | 0 |
| Ability to Withdraw (Right Ventricle): Score 4 | 0 |
| Ability to Withdraw (Right Ventricle): Score 5 | 0 |
| Ability to Withdraw (Right Ventricle): Score 6 | 1 |
| Ability to Withdraw (Right Ventricle): Score 7 | 0 |
| Insertion/ Withdrawal from Introducer Sheath: Score 1 | 0 |
| Insertion/ Withdrawal from Introducer Sheath: Score 2 | 0 |
| Insertion/ Withdrawal from Introducer Sheath: Score 3 | 1 |
| Insertion/ Withdrawal from Introducer Sheath: Score 4 | 2 |
| Insertion/ Withdrawal from Introducer Sheath: Score 5 | 9 |
| Insertion/ Withdrawal from Introducer Sheath: Score 6 | 9 |
| Insertion/ Withdrawal from Introducer Sheath: Score 7 | 10 |
| Learning Curve: Score 1 | 0 |
| Learning Curve: Score 2 | 0 |
| Learning Curve: Score 3 | 0 |
| Learning Curve: Score 4 | 4 |
| Learning Curve: Score 5 | 4 |
| Learning Curve: Score 6 | 18 |
| Learning Curve: Score 7 | 5 |
Number of responders for physician assessment for signal collection and quality 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 | OPTRELL Mapping Catheter |
|---|---|
| UNIPOLAR signals in Atrium: Score 1 | 0 |
| UNIPOLAR signals in Atrium: Score 2 | 0 |
| UNIPOLAR signals in Atrium: Score 3 | 0 |
| UNIPOLAR signals in Atrium: Score 4 | 0 |
| UNIPOLAR signals in Atrium: Score 5 | 1 |
| UNIPOLAR signals in Atrium: Score 6 | 4 |
| UNIPOLAR signals in Atrium: Score 7 | 2 |
| UNIPOLAR signals in Ventricle: Score 1 | 0 |
| UNIPOLAR signals in Ventricle: Score 2 | 0 |
| UNIPOLAR signals in Ventricle: Score 3 | 0 |
| UNIPOLAR signals in Ventricle: Score 4 | 1 |
| UNIPOLAR signals in Ventricle: Score 5 | 3 |
| UNIPOLAR signals in Ventricle: Score 6 | 4 |
| UNIPOLAR signals in Ventricle: Score 7 | 0 |
| UNIPOLAR noise encountered: Score 1 | 0 |
| UNIPOLAR noise encountered: Score 2 | 0 |
| UNIPOLAR noise encountered: Score 3 | 0 |
| UNIPOLAR noise encountered: Score 4 | 1 |
| UNIPOLAR noise encountered: Score 5 | 4 |
| UNIPOLAR noise encountered: Score 6 | 7 |
| UNIPOLAR noise encountered: Score 7 | 4 |
| BIPOLAR signals in Atrium: Score 1 | 0 |
| BIPOLAR signals in Atrium: Score 2 | 0 |
| BIPOLAR signals in Atrium: Score 3 | 0 |
| BIPOLAR signals in Atrium: Score 4 | 0 |
| BIPOLAR signals in Atrium: Score 5 | 0 |
| BIPOLAR signals in Atrium: Score 6 | 7 |
| BIPOLAR signals in Atrium: Score 7 | 16 |
| BIPOLAR signals in Ventricle: Score 1 | 0 |
| BIPOLAR signals in Ventricle: Score 2 | 0 |
| BIPOLAR signals in Ventricle: Score 3 | 0 |
| BIPOLAR signals in Ventricle: Score 4 | 0 |
| BIPOLAR signals in Ventricle: Score 5 | 1 |
| BIPOLAR signals in Ventricle: Score 6 | 7 |
| BIPOLAR signals in Ventricle: Score 7 | 1 |
| BIPOLAR noise encountered: Score 1 | 0 |
| BIPOLAR noise encountered: Score 2 | 0 |
| BIPOLAR noise encountered: Score 3 | 0 |
| BIPOLAR noise encountered: Score 4 | 1 |
| BIPOLAR noise encountered: Score 5 | 3 |
| BIPOLAR noise encountered: Score 6 | 12 |
| BIPOLAR noise encountered: Score 7 | 15 |
Number of responders for physician assessment for pacing (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 | OPTRELL Mapping Catheter |
|---|---|
| Local pacing capture: Score 1 | 0 |
| Local pacing capture: Score 2 | 0 |
| Local pacing capture: Score 3 | 1 |
| Local pacing capture: Score 4 | 1 |
| Local pacing capture: Score 5 | 2 |
| Local pacing capture: Score 6 | 2 |
| Local pacing capture: Score 7 | 3 |
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 in OPTRELL catheter for mapping.
| Participants | OPTRELL Mapping 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 | 2 |
| Ability to achieve electrode contact with cardiac tissue: Score 5 | 2 |
| Ability to achieve electrode contact with cardiac tissue: Score 6 | 18 |
| Ability to achieve electrode contact with cardiac tissue: Score 7 | 8 |
| Electrodes spacing: Score 1 | 0 |
| Electrodes spacing: Score 2 | 1 |
| Electrodes spacing: Score 3 | 0 |
| Electrodes spacing: Score 4 | 0 |
| Electrodes spacing: Score 5 | 0 |
| Electrodes spacing: Score 6 | 13 |
| Electrodes spacing: Score 7 | 17 |
| Electrode array coverage: Score 1 | 0 |
| Electrode array coverage: Score 2 | 1 |
| Electrode array coverage: Score 3 | 0 |
| Electrode array coverage: Score 4 | 0 |
| Electrode array coverage: Score 5 | 0 |
| Electrode array coverage: Score 6 | 9 |
| Electrode array coverage: Score 7 | 21 |
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 | OPTRELL Mapping Catheter |
|---|---|
| Ability to reduce fluoroscopy: Score 1 | 0 |
| Ability to reduce fluoroscopy: Score 2 | 0 |
| Ability to reduce fluoroscopy: Score 3 | 0 |
| Ability to reduce fluoroscopy: Score 4 | 10 |
| Ability to reduce fluoroscopy: Score 5 | 6 |
| Ability to reduce fluoroscopy: Score 6 | 10 |
| Ability to reduce fluoroscopy: Score 7 | 5 |
| Time for pre-procedure mapping: Score 1 | 0 |
| Time for pre-procedure mapping: Score 2 | 0 |
| Time for pre-procedure mapping: Score 3 | 0 |
| Time for pre-procedure mapping: Score 4 | 8 |
| Time for pre-procedure mapping: Score 5 | 4 |
| Time for pre-procedure mapping: Score 6 | 10 |
| Time for pre-procedure mapping: Score 7 | 9 |
| 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 | 0 |
| 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 | 2 |
| Time for post-procedure mapping after standard of care ablation: Score 5 | 4 |
| Time for post-procedure mapping after standard of care ablation: Score 6 | 9 |
| Time for post-procedure mapping after standard of care ablation: Score 7 | 9 |
| 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 | 1 |
| Ability to identify targets: Score 5 | 0 |
| Ability to identify targets: Score 6 | 13 |
| Ability to identify targets: Score 7 | 14 |
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 | OPTRELL Mapping Catheter |
|---|---|
| Visualization under fluoroscopy: Score 1 | 0 |
| Visualization under fluoroscopy: Score 2 | 0 |
| Visualization under fluoroscopy: Score 3 | 0 |
| Visualization under fluoroscopy: Score 4 | 0 |
| Visualization under fluoroscopy: Score 5 | 7 |
| Visualization under fluoroscopy: Score 6 | 9 |
| Visualization under fluoroscopy: Score 7 | 15 |
| Visualization in CARTO 3: Score 1 | 0 |
| Visualization in CARTO 3: Score 2 | 0 |
| Visualization in CARTO 3: Score 3 | 0 |
| Visualization in CARTO 3: Score 4 | 0 |
| Visualization in CARTO 3: Score 5 | 3 |
| Visualization in CARTO 3: Score 6 | 10 |
| Visualization in CARTO 3: Score 7 | 18 |
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 | OPTRELL Mapping Catheter |
|---|---|
| With CARTO 3 System: Score 1 | 0 |
| With CARTO 3 System: Score 2 | 0 |
| With CARTO 3 System: Score 3 | 0 |
| With CARTO 3 System: Score 4 | 0 |
| With CARTO 3 System: Score 5 | 4 |
| With CARTO 3 System: Score 6 | 12 |
| With CARTO 3 System: Score 7 | 15 |
| EP Lab recording equipment: Score 1 | 0 |
| EP Lab recording equipment: Score 2 | 0 |
| EP Lab recording equipment: Score 3 | 0 |
| EP Lab recording equipment: Score 4 | 1 |
| EP Lab recording equipment: Score 5 | 8 |
| EP Lab recording equipment: Score 6 | 12 |
| EP Lab recording equipment: Score 7 | 10 |
| Pacing equipment: Score 1 | 0 |
| Pacing equipment: Score 2 | 0 |
| Pacing equipment: Score 3 | 0 |
| Pacing equipment: Score 4 | 0 |
| Pacing equipment: Score 5 | 4 |
| Pacing equipment: Score 6 | 3 |
| Pacing equipment: Score 7 | 7 |
| Introducer tool on catheter: Score 1 | 0 |
| Introducer tool on catheter: Score 2 | 0 |
| Introducer tool on catheter: Score 3 | 0 |
| Introducer tool on catheter: Score 4 | 3 |
| Introducer tool on catheter: Score 5 | 6 |
| Introducer tool on catheter: Score 6 | 14 |
| Introducer tool on catheter: Score 7 | 8 |
| Sheath: Score 1 | 0 |
| Sheath: Score 2 | 0 |
| Sheath: Score 3 | 0 |
| Sheath: Score 4 | 3 |
| Sheath: Score 5 | 6 |
| Sheath: Score 6 | 14 |
| Sheath: Score 7 | 8 |
| Irrigation bag and tubing: Score 1 | 0 |
| Irrigation bag and tubing: Score 2 | 0 |
| Irrigation bag and tubing: Score 3 | 0 |
| Irrigation bag and tubing: Score 4 | 0 |
| Irrigation bag and tubing: Score 5 | 5 |
| Irrigation bag and tubing: Score 6 | 15 |
| Irrigation bag and tubing: Score 7 | 11 |
| 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 | 1 |
| ICD or other implantable devices: Score 5 | 2 |
| ICD or other implantable devices: Score 6 | 2 |
| ICD or other implantable devices: Score 7 | 3 |
Number of responders with 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 | OPTRELL Mapping Catheter |
|---|---|
| Compared to the PENTARAY catheter?: Score 1 | 0 |
| Compared to the PENTARAY catheter?: Score 2 | 0 |
| Compared to the PENTARAY catheter?: Score 3 | 0 |
| Compared to the PENTARAY catheter?: Score 4 | 2 |
| Compared to the PENTARAY catheter?: Score 5 | 5 |
| Compared to the PENTARAY catheter?: Score 6 | 10 |
| Compared to the PENTARAY catheter?: Score 7 | 14 |
| 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 | 0 |
| Compared to other competitive multielectrode catheters?: Score 5 | 5 |
| Compared to other competitive multielectrode catheters?: Score 6 | 19 |
| Compared to other competitive multielectrode catheters?: Score 7 | 1 |
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 | OPTRELL Mapping Catheter |
|---|---|
| Compared to the PENTARAY catheter?: Score 1 | 0 |
| Compared to the PENTARAY catheter?: Score 2 | 0 |
| Compared to the PENTARAY catheter?: Score 3 | 0 |
| Compared to the PENTARAY catheter?: Score 4 | 3 |
| Compared to the PENTARAY catheter?: Score 5 | 2 |
| Compared to the PENTARAY catheter?: Score 6 | 7 |
| Compared to the PENTARAY catheter?: Score 7 | 9 |
| 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 | 4 |
| Compared to other competitive multielectrode catheters?: Score 5 | 0 |
| Compared to other competitive multielectrode catheters?: Score 6 | 13 |
| Compared to other competitive multielectrode catheters?: Score 7 | 4 |
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 | OPTRELL Mapping Catheter |
|---|---|
| Compared to the PENTARAY catheter?: Score 1 | 0 |
| Compared to the PENTARAY catheter?: Score 2 | 0 |
| Compared to the PENTARAY catheter?: Score 3 | 0 |
| Compared to the PENTARAY catheter?: Score 4 | 0 |
| Compared to the PENTARAY catheter?: Score 5 | 0 |
| Compared to the PENTARAY catheter?: Score 6 | 16 |
| Compared to the PENTARAY catheter?: Score 7 | 15 |
| 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 | 0 |
| Compared to other competitive multielectrode catheters?: Score 5 | 0 |
| Compared to other competitive multielectrode catheters?: Score 6 | 25 |
| Compared to other competitive multielectrode catheters?: Score 7 | 0 |
Collected over Up to 72 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OPTRELL Mapping Catheter | 0/31 (0%) | 3/31 (9.7%) | 7/31 (22.6%) |
| Event | OPTRELL Mapping Catheter |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 1/31 |
| Catheter site injuryGeneral disorders | 1/31 |
| Vascular pseudoaneurysmInjury, poisoning and procedural complications | 1/31 |
| Peripheral artery haematomaVascular disorders | 1/31 |
| Event | OPTRELL Mapping Catheter |
|---|---|
| FatigueGeneral disorders | 2/31 |
| Left ventricular dilatationCardiac disorders | 1/31 |
| Left ventricular dysfunctionCardiac disorders | 1/31 |
| Abdominal pain, upperGastrointestinal disorders | 1/31 |
| Ear infectionInfections and infestations | 1/31 |
| Lower limb fractureInjury, poisoning and procedural complications | 1/31 |
| ParaesthesiaNervous system disorders | 1/31 |
| Anxiety disorderPsychiatric disorders | 1/31 |
| Age, Continuous(years) | OPTRELL Mapping Catheter |
|---|---|
| Mean | 59.8 ± 14.40 |
| Sex: Female, Male(Participants) | OPTRELL Mapping Catheter |
|---|---|
| Female | 9 |
| Male | 22 |
| Race and Ethnicity Not Collected(Participants) | OPTRELL Mapping 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 Aug 2021 to primary completion in Nov 2021, 2 months.
Results were first posted in Jan 2023, 1 year 2 months 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 2 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 Jun 2023. You cannot join it, but the record below documents what was studied.
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