An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

An Observational Post-marketing Study for Evaluation of Ongoing Safety and Effectiveness of Catheter Mapping and Ablation Using Commercially Approved BWI Medical Devices for the Treatment of Patients With Cardiac Arrhythmias

ClinicalTrials.gov ID

NCT04750798

Acronym / sponsor ID

SECURE / BWI_2019_05

Conditions

Arrhythmias, Cardiac

Study type

Observational

Recruitment status

Recruiting

Enrolment

8,000 participants (estimated)

Lead sponsor

Biosense Webster, Inc.Industry (pharma, biotech, devices)

Study start

22 Feb 2021 (actual)

Primary completion

31 Dec 2036 (estimated)

Study completion

31 Dec 2037 (estimated)

First posted

11 Feb 2021 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

1

Who may qualify

Sex

All

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

Study population

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. 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

   Time frame: Up to 7 Days

   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.

2. AF: Number of Participants with Isolation of all Targeted Pulmonary Veins

   Time frame: Up to 7 Days

   Number of Participants with isolation (entrance block confirmation) of all targeted pulmonary veins will be reported.

3. 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

   Time frame: Up to 7 Days

   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.

4. SVT (MRAT): Number of Participants with Complete Bidirectional Conduction Block Across the Ablation Line

   Time frame: Up to 7 Days

   Number of participants with Macro Re-entrant Atrial Tachycardia (MRAT) with complete bidirectional conduction block across the ablation line will be reported.

5. SVT (AVRT): Number of Participants with Complete Block of Accessory Pathway

   Time frame: Up to 7 Days

   Number of participants with atrioventricular reentry tachycardia (AVRT) with complete block of accessory pathway will be reported.

6. VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of the Targeted VT at end of Procedure

   Time frame: Up to 7 days

   Number of participants with non-inducibility of the targeted ischemic or non-ischemic VT at end of procedure will be reported.

7. VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant VT

   Time frame: Up to 7 days

   Number of participants with elimination of clinically relevant idiopathic VT will be reported. Clinically relevant: any spontaneous VT or any induced VT.

8. VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs)

   Time frame: Up to 7 days

   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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
• Derived from this study: PubMed 42392466Almorad A, Sebag FA, Kronborg MB, Sohns C, De Potter T, Adragao P, Bessiere F, Chierchia GB, Duytschaever M, Szeplaki G, Di Monaco A, Reichlin T, Yap SC, Wong T, Lepiece C, Linz D, Gallagher MM, Pappone C, Sommer P, Ernst S, Purerfellner H, Scherr D; VARIPURE Investigators. Pulsed field ablation with a variable loop circular catheter in atrial fibrillation: Acute outcomes from the VARIPURE multicenter study. Heart Rhythm. 2026 Jul 2:S1547-5271(26)02516-6. doi: 10.1016/j.hrthm.2026.06.040. Online ahead of print.
• Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

46 sites in 15 countries: see every site and its status.