An interventional study of Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter in Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation and Paroxysmal Atrial Fibrillation, sponsored by Biosense Webster, Inc.. Recruiting at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Biosense Webster, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Device feasibility
The purpose of this study is to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 90 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 scheduled to have a clinically indicated mapping and ablation procedure for the management of cardiac arrhythmias. The investigational paddle-shaped, high-density, multi-electrode catheter is used for mapping purposes only.
Device: Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter
High-density, multi-electrode mapping catheter will be used for the procedure.
Occurrence of Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter When Used for Endocardial Mapping
A SAE is any AE that led to any of the following: (1) Death; (2) Serious deterioration in the health of a participant that resulted in any of the following: Life-threatening illness or injury; Permanent impairment of a body structure or a body function; In-patient hospitalization or prolongation of patient hospitalization; Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; Chronic disease. (3) Fetal distress, fetal death or a congenital physical or mental impairment or birth defect.
Time frame: Up to 7 days post index procedure
Occurrence of Completion of All Pre-Ablation Endocardial Mapping Requirements and Any Clinically Indicated Endocardial Mapping
Occurrence of all pre-ablation endocardial mapping requirements and any clinically indicated endocardial mapping with the investigational catheter, without resort to non-investigational mapping catheter due to an inadequacy or inability of the investigational catheter to perform the required arrhythmia mapping will be reported.
Time frame: Up to 7 days post index procedure
Investigator Assessment of Deployment; Visualization; Maneuverability and Signal Quality
Physician feedback on the catheter deployment, visualization, maneuverability, and signal quality acquired with the investigational catheter for mapping of the atria and ventricles, inclusive of endocardial and epicardial spaces, using a physician-completed survey, using a Likert scale of 1 to 7 (1=poor and 7=excellent) will be summarized.
Time frame: Up to 7 days post index procedure
Occurrence of SAEs Related to the Investigational Catheter When Used for Epicardial Mapping as per Physician's Discretion
A SAE is any AE that led to any of the following: (1) Death; (2) Serious deterioration in the health of a participant that resulted in any of the following: Life-threatening illness or injury; Permanent impairment of a body structure or a body function; In-patient hospitalization or prolongation of patient hospitalization; Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; Chronic disease. (3) Fetal distress, fetal death or a congenital physical or mental impairment or birth defect.
Time frame: Up to 7 days post index procedure
Occurrence of all Other SAEs Not Related to the Investigational Catheter
Occurrence of all other SAEs not related to the investigational catheter will be reported.
Time frame: Up to 7 days post index procedure
Occurrence of Non-serious Adverse Events (AEs) Related to the Investigational Catheter
Occurrence of non-serious AEs related to the investigational catheter will be reported.
Time frame: Up to 7 days post index procedure
Occurrence of Completion of all Pre-ablation Epicardial Mapping Requirements and Any Clinically Indicated Epicardial Mapping With the Investigational Catheter as Per Physician's Discretion
Occurrence of completion with all pre-ablation epicardial mapping requirements and any clinically indicated epicardial mapping with the investigational catheter as per physician's discretion, without resort to non-investigational mapping catheter due to an inadequacy or inability of the investigational catheter to perform the required arrhythmia mapping will be reported.
Time frame: Up to 7 days post index procedure
Plan to share: Yes — The data sharing policy of Johnson \& Johnson MedTech is available at https://www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · www.jnj.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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