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Repeat Ablation for Persistent Atrial Fibrillation with FARAPULSE System

This study is testing the safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation System, including the FARAWAVE™ and FARAPOINT™ catheters, for people with persistent atrial fibrillation (PersAF). PersAF is a type of irregular heartbeat that doesn't go away on its own. This treatment is for individuals who have already had one heart ablation procedure for their atrial fibrillation that didn't fully work. The study aims to see how many people have a successful procedure within 24 hours and to track any safety issues for 60 days. You may be able to join if you are 18 or older, have had a previous ablation for persistent atrial fibrillation, and have a documented diagnosis of PersAF. The current recruitment status for this study is unclear.

Study design
This is a single-arm, open-label study planning to enroll 376 participants. It is designed to evaluate the FARAPULSE PFA System.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured at 60 days, and effectiveness will be measured at 24 hours after the procedure.

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

NCT06735534

Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System

Recruiting
NAAges 18+InterventionalTreatment
Boston Scientific Corporation
~376 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:FARAPULSE™ Pulsed Field Ablation System

At a glance

Recruiting sites
41 of 41 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary safety endpoint rate
Measured over 60 days
+1 more outcome measured

Conditions

Persistent Atrial Fibrillation

Explore related trials

Persistent atrial fibrillation

NCT06735534

Where you'd take part

This study runs at 41 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AdventHealth Orlando-Hospital

    Orlando, Floridastudy coordinator listed

    Recruiting

  • AdventHealth Tampa-Hospital

    Tampa, Floridastudy coordinator listed

    Recruiting

  • Advocate Christ Medical Center-Hospital

    Oak Lawn, Illinoisstudy coordinator listed

    Recruiting

  • Arrhythmia Research Group-Research Facility

    Jonesboro, Arkansasstudy coordinator listed

    Recruiting

  • Atrium Health Navicent The Medical Center

    Macon, Georgiastudy coordinator listed

    Recruiting

  • Bethesda North Hospital

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

  • Christus Trinity Mother Frances Health System

    Tyler, Texasstudy coordinator listed

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshirestudy coordinator listed

    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

  • Moussa Mansour,, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Kristin Mathson
[email protected]
612.417.9538
Email the study team

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Eligibility criteria

Inclusion

≥ 18 years of age, or older if required by local law
Single previous endocardial AF ablation procedure for PAF or PersAF that minimally included pulmonary vein isolation
Documented (physician's note) diagnosis of PersAF either prior to the subject's Index Procedure OR development of PersAF after the Index Procedure.
Documented evidence of symptomatic AF recurrence at least 60 days after the subject's Index Procedure, captured by any regulatory cleared rhythm monitoring device.
If diagnosed with PersAF prior to the Index Procedure, documented recurrence of symptomatic AF or atypical AFL at least 60 days after the Index Procedure, captured by any regulatory cleared rhythm monitoring device.
Willing and capable of providing informed consent
Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center

Exclusion

Moderate to severe aortic stenosis 5. Hypertrophic cardiomyopathy 6. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access 7. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months 8. Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data. 3. Any of the following conditions at baseline:

What this trial measures

  • Primary safety endpoint rate60 days

    The primary safety endpoint (PSE) is the proportion of Treatment subjects with one or more device or procedure-related Composite Serious Adverse Events (CSAEs) following the Repeat Ablation Procedure.

  • The primary effectiveness endpoint is the proportion of Treatment subjects with Acute Procedural Success.24 hours

    The proportion of Treatment Subjects with confirmed electrical block across all anatomical locations ablated with the investigational system only (Acute Procedural Success).