An observational study in Arrhythmias, Cardiac, sponsored by Biosense Webster, Inc.. Recruiting at 47 sites in 15 countries. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Biosense Webster, Inc. (part of Johnson & Johnson) · Observational
The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial Biosense Webster Inc. (BWI) medical devices. Data generated from the study will be used to confirm safety and performance of BWI medical devices in the marketed phase and to expand the body of evidence on the use of these devices and techniques in treatment of cardiac arrhythmias.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's planned enrollment of 8,000 is above the median of 200 across 467 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac 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.
Study population consists of participants diagnosed with cardiac arrhythmias who are scheduled to undergo an ablation procedure for management of their arrhythmia with a per-protocol defined Biosense Webster Inc (BWI) therapeutic catheter.
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.
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 study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Patients diagnosed with cardiac arrhythmias who are scheduled to undergo an ablation procedure in routine clinical practice for management of their arrhythmia with a BWI therapeutic catheter/Varipulse Catheter/ Dual Energy Thermocool Smarttouch surround flow (SF) catheter will be observed.
Device: BWI Medical Device · Device: Varipulse Catheter · Device: Dual Energy THERMOCOOL SMARTTOUCH SF Catheter
Participants will be treated with commercially approved BWI medical devices following routine clinical practice. No specific intervention will be observed for this study.
Participants treated with Varipulse Catheter in the main study will be part of the VARIPURE sub-study. No specific intervention will be observed for this study.
Participants treated with the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter in the main study will be part of the DUACURE sub-study. No specific intervention will be observed for this study.
Number of Participants with Primary Adverse Events (PAEs) Related to Device in Scope and/or Study Procedure Within 7 Days of the Initial Study Procedure
PAEs in participants with Atrial Fibrillation (AF) and for SupraVentricular Tachycardia (SVT) includes device or procedure related death, atrio-esophageal fistula/ esophageal perforation , severe pulmonary vein stenosis, cardiac tamponade/perforation, thromboembolism, pericarditis, stroke/cerebrovascular accident, transient ischemic attack, phrenic nerve paralysis (permanent), myocardial infarction, major vascular access complication/bleeding, heart block; PAEs in participants with Ventricular Tachycardia (VT) includes device or procedure related death, cardiac tamponade/perforation, thromboembolism, pericarditis, stroke/cerebrovascular accident, transient ischemic attack, phrenic nerve paralysis (permanent), myocardial infarction, major vascular access complication/bleeding, heart block, aggravation or new onset heart failure, coronary artery injury, aortic dissection and valve injury.
Time frame: Up to 7 Days
AF: Number of Participants with Isolation of all Targeted Pulmonary Veins
Number of Participants with isolation (entrance block confirmation) of all targeted pulmonary veins will be reported.
Time frame: Up to 7 Days
SVT (Sinus Nodal Re-entrant Tachycardia, Focal AT, Multifocal AT, AVNRT, Non Re-entrant Junctional Tachycardias): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure
Number of participants with sinus nodal re-entrant tachycardia, focal atrial tachycardia (AT) multifocal AT, atrioventricular nodal reentry tachycardia (AVNRT), non re-entrant junctional tachycardias with non-inducibility of the targeted tachycardia at end of procedure will be reported.
Time frame: Up to 7 Days
SVT (MRAT): Number of Participants with Complete Bidirectional Conduction Block Across the Ablation Line
Number of participants with Macro Re-entrant Atrial Tachycardia (MRAT) with complete bidirectional conduction block across the ablation line will be reported.
Time frame: Up to 7 Days
SVT (AVRT): Number of Participants with Complete Block of Accessory Pathway
Number of participants with atrioventricular reentry tachycardia (AVRT) with complete block of accessory pathway will be reported.
Time frame: Up to 7 Days
VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of the Targeted VT at end of Procedure
Number of participants with non-inducibility of the targeted ischemic or non-ischemic VT at end of procedure will be reported.
Time frame: Up to 7 days
VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant VT
Number of participants with elimination of clinically relevant idiopathic VT will be reported. Clinically relevant: any spontaneous VT or any induced VT.
Time frame: Up to 7 days
VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs)
Number of participants with elimination of clinically relevant idiopathic PVCs will be reported. Clinically relevant: any spontaneous PVC or any induced PVC; prior to treatment, PVCs would be deemed clinically relevant if they are present greater than (\>) 20 percent (%) of daily heartbeat.
Time frame: Up to 7 days
Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs])
Number of participants with device and/or procedure-related Serious Adverse Events (SADEs) within 7 days (early-onset), \>7-30 days (peri-procedural) and \>30 days (late onset) following the initial study procedure will be reported.
Time frame: Up to 365 Days
Number of Participants with Device and/or Procedure-Related Non-Serious Adverse Events (Non-Serious Adverse Device Effects [ADEs])
Number of participants with device and/or procedure-related non-serious adverse events (Non-serious ADEs) within 7 days (early-onset), \>7-30 days (peri-procedural) and \>30 days (Late Onset) following the initial study procedure will be reported.
Time frame: Up to 365 Days
AF: Number of Participants with Acute Reconnection Among all Targeted Pulmonary Veins (PVs)
Number of participants with Acute reconnection among all targeted PVs will be reported.
Time frame: Up to 7 Days
SVT (MRAT): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure
Number of participants with MRAT with non-inducibility of the targeted tachycardia at end of procedure will be reported.
Time frame: Up to 7 Days
SVT (AVNRT): Number of Participants with Elimination or Modification of Slow Pathway Conduction
Number of participants with AVNRT with elimination or modification of slow pathway conduction will be reported.
Time frame: Up to 7 Days
VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of any VT at end of Procedure
Number of participants with non-inducibility of any VT (Ischemic or Non-ischemic) at end of procedure will be reported.
Time frame: Up to 7 Days
VT (Ischemic or Non-ischemic): Number of Participants with Elimination of all Targeted Late Potentials and Local Abnormal Ventricular Activation (LAVAs) at end of Procedure
Number of participants with elimination of all targeted late potentials and local abnormal ventricular activation (LAVAs) at end of procedure will be reported.
Time frame: Up to 7 Days
AF: Number of Participants with Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes
Number of participants with freedom from documented (symptomatic and asymptomatic) AF, AT, AFL episodes (episodes greater than or equal to \[\>=\] 30 seconds) post-blanking will be reported.
Time frame: From Day 91 to Day 365 (post-blanking)
AF: Number of Participants with Freedom From Documented Symptomatic AF, AT, AFL Episodes
Number of participants with freedom from documented symptomatic AF, AT, AFL episodes (episodes \>= 30 seconds) post-blanking will be reported.
Time frame: From Day 91 to Day 365 (post-blanking)
AF: Number of Participants with Repeated Ablation
Number of participants with repeated ablation post-blanking will be reported.
Time frame: From Day 91 to Day 365 (post-blanking)
AF: Number of Participants with Repeated Ablation with Pulmonary Vein (PV) Reconnection
Number of participants with repeated ablation with PV reconnection post blanking will be reported.
Time frame: From Day 91 to Day 365 (post-blanking)
SVT: Number of Participants with Freedom From Documented Arrhythmia of the Primary SVT
Number of participants with freedom from documented arrhythmia of the primary SVT (episodes \>=30 seconds) will be reported.
Time frame: From Day 1 to Day 365
SVT: Number of Participants with Freedom From Documented Arrhythmia of new SVT, not Targeted During Index Procedure
Number of participants with freedom from documented arrhythmia of new SVT, not targeted during index procedure will be reported.
Time frame: From Day 1 to Day 365
SVT: Number of Participants with Repeated Ablation
Number of participants with repeated ablation will be reported.
Time frame: From Day 1 to Day 365
VT: Number of Participants with Freedom From Documented Arrhythmia of the Clinically Relevant/Targeted VT
Number of participants with freedom from documented arrhythmia of the clinically relevant /targeted VT (episodes \>=30 seconds) will be reported.
Time frame: From Day 1 to Day 365
VT: Number of Participants with Freedom From Documented Arrhythmia of new VT, not Targeted During Index Procedure
Number of participants with freedom from documented arrhythmia of new VT, not targeted during index procedure will be reported.
Time frame: From Day 1 to Day 365
VT: Number of Participants with Repeated Ablation
Number of participants with repeated ablation will be reported.
Time frame: From Day 1 to Day 365
VT: Number of Participants with All Cause and Cardiac Mortality
Number of participants with all cause and cardiac mortality will be reported.
Time frame: Up to Day 365
VT: Number of Participants with Heart Failure Hospitalization
Number of participants with heart failure hospitalization will be reported.
Time frame: Up to Day 365
VARIPURE sub-study: Number of Participants With Coronary Spasm During Ablation
Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with coronary spasm during ablation will be reported.
Time frame: Up to Day 365
VARIPURE Sub-Study: Number of Participants With Vagal Response During Ablation
Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with vagal response during ablation will be reported.
Time frame: Up to Day 365
VARIPURE Sub-Study: Number of Participants With Acute Kidney Failure Post Ablation
Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with acute kidney failure post ablation will be reported.
Time frame: Up to Day 365
DUACURE Sub-Study: Number of Participants With Coronary Spasm During Ablation
Ablation procedures using the duacure medical device will be performed according to the hospital standard practice. Number of participants with coronary spasm during ablation will be reported.
Time frame: Up to Day 365
DUACURE Sub-Study: Number of Participants With Vagal Response During Ablation
Ablation procedures using the duacure medical device will be performed according to the hospital standard practice. Number of participants with vagal response during ablation will be reported.
Time frame: Up to Day 365
DUACURE Sub-Study: Number of Participants With Acute Kidney Failure Post Ablation
Ablation procedures using the duacure medical device will be performed according to the hospital standard practice. Number of participants with acute kidney failure post ablation will be reported.
Time frame: Up to Day 365
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Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/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 ↗ · innovativemedicine.jnj.com
Started Feb 2021 (actual). Primary completion is estimated for Dec 2036, 190 months after the start.
Of 69 industry-sponsored observational studies under Arrhythmias, Cardiac, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 51. This study's planned 190 months is above that.
Counting every sponsor, half of 258 studies reached it within 38 months; a quarter within 16 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
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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