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REPRESENT-PF Registry for Atrial Fibrillation Treatment

This registry is observing the use of the FARAWAVE Pulsed Field Ablation (PFA) Catheter in patients with persistent or paroxysmal atrial fibrillation (AF). The FARAWAVE Catheter is part of the FARAPULSE PFA System, which uses electrical pulses to treat AF. This study aims to understand how safe and effective this treatment is for people from underrepresented racial and ethnic minority groups. Researchers will look for serious side effects up to 60 days after the procedure and check if the treatment successfully controls AF after 12 months. You may be able to join if you are 18 or older, are from a racial or ethnic minority group, and are having this type of ablation for symptomatic AF. The study is currently unclear on its recruitment status.

Study design
This is an observational registry, meaning researchers will collect information from 275 patients receiving standard care. It is a single-arm study, so all participants will receive the same treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants for serious side effects up to 60 days after the procedure and for treatment success at 12 months.

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

NCT07535268

REPRESENT-PF Registry

Recruiting
Not specifiedAges 18+Observational
Vivek Reddy
~275 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:FARAWAVE Pulsed Field Ablation Catheter

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite Serious Adverse Events
Measured over up to Day 60 Post Procedure
+1 more outcome measured

Conditions

Persistent Atrial Fibrillation
Paroxysmal Atrial Fibrillation

Explore related trials

Paroxysmal Atrial FibrillationPersistent atrial fibrillation

NCT07535268

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The Mount Sinai Hospital

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Valley Health System

    Winchester, Virginiastudy 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

  • Vivek Reddy, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Devin Chamberlain
[email protected]
(646) 984-1049
Email the study team

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Eligibility criteria

Inclusion

All consecutive patients classified as racial or ethnic minorities undergoing ablation using Boston Scientific FDA approved PFA catheters for AF will be included.
De novo ablation for symptomatic paroxysmal and persistent AF (Age ≥ 18) (unless it is a repeat for a patient whose index procedure is also in the registry) who are deemed to be candidates for AF ablation by the investigator.
Able and willing to participate in baseline and follow up evaluation over the study period
Willing and able to provide informed consent, if applicable.

Exclusion

Enrolled in an investigational drug or device clinical trial or any other trial with outlined treatment plan
Long standing persistent AF (AF \> 1 year duration)
Repeat ablation, unless index ablation procedure was in the REPRESENT-PF registry
Any known contra-indication to ablation procedure at the discretion of the investigator

What this trial measures

  • Composite Serious Adverse Eventsup to Day 60 Post Procedure

    Assess device- or procedure-related Composite Serious Adverse Events (CSAEs) assessed through Day 60 following the Ablation Procedure The proportion of all Treatment Subjects and Attempt Subjects (combined PAF and PersAF cohort) with one or more device- or procedure-related Composite Serious Adverse Events (CSAEs) assessed through Day 60 following the Ablation Procedure on or prior to the Day 60 Assessment, with an Onset Date following the procedure.

  • Chronic Treatment Success12 Months

    Chronic treatment success is defined as freedom from any of the following through the Day 365: * Arrhythmia: Occurrence of any detectable AF, AFL or AT * Re-ablation: Any re-ablation for AF, AFL or AT at any time following the index procedure after the blanking period. * Cardioversion: Any electrical cardioversion for AF, AFL or AT