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Long-Term Safety and Effectiveness of VARIPULSE Catheter System for Atrial Fibrillation

This study is looking at the long-term safety and effectiveness of the FDA-approved VARIPULSE Catheter System with TRUPULSE Generator. This system is used for a procedure called pulmonary vein isolation (PVI) to treat symptomatic paroxysmal atrial fibrillation (PAF), which is a type of irregular heartbeat. The study wants to see if the treatment causes any early serious problems within 7 days and if it helps people stay free from irregular heartbeats for up to 3 years. You might be able to join if you have symptomatic PAF, are a candidate for catheter ablation, and haven't responded well to or can't take certain heart medications. The study plans to enroll 276 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 276 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 1095 days (about 3 years) after their procedure to check for freedom from irregular heartbeats.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07227532

A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System

Recruiting
NAAges 22+InterventionalTreatment
Biosense Webster, Inc.
~276 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator

At a glance

Recruiting sites
22 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure
Measured over Within 7 days post index procedure
+1 more outcome measured

Conditions

Atrial Fibrillation

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Atrial Fibrillation

NCT07227532

Where you'd take part

This study runs at 22 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Albert Einstein College Of Medicine - Montefiore Medical Center

    The Bronx, New Yorkno site contact published

    Recruiting

  • Aurora Denver Cardiology Associates

    Aurora, Coloradono site contact published

    Recruiting

  • Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano

    Plano, Texasno site contact published

    Recruiting

  • Baylor Scott and White Research Institute

    Fort Worth, Texasno site contact published

    Recruiting

  • Community Memorial Hospital

    Ventura, Californiano site contact published

    Recruiting

  • Edward Hospital Midwest Cardiovascular Institute

    Naperville, Illinoisno site contact published

    Recruiting

  • HCA Florida Mercy Hospital

    Miami, Floridano site contact published

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Biosense Webster, Inc. Clinical Trial · STUDY_DIRECTOR · Biosense Webster, Inc.

Who to contact

Emily Purcell
[email protected]
+1 949 230 3701
Email the study team

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Eligibility criteria

Inclusion

Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF
Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD)
Willing and capable of providing consent
Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion

Previously diagnosed with persistent or long-standing persistent AF (more than \[\>\] 7 days in duration)
Previous surgical or catheter ablation for AF
Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
Current enrollment in an investigational study evaluating another device or drug
Life expectancy less than 12 months
Any contraindications as defined in the Protocol

What this trial measures

  • Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation ProcedureWithin 7 days post index procedure

    PAE's will include the following adverse events: atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.

  • Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias EpisodesDay 61-1095 post-index procedure

    Freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmias (atrial fibrillation \[AF\], atrial tachycardia \[AT\] or atrial flutter \[AFL\] of unknown origin) episodes will be reported. AFL of unknown origin is defined as all AFL except those Cavotricuspid isthmus CTI dependent AFL as confirmed by 12-Lead electrocardiogram (ECG) and entrainment maneuvers in an evaluation period study.