REPRESENT-PF Registry

NCT07535268 | Recruiting FDA Device

• 1 other identifier: STUDY-25-01408
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 2

Brief Summary

This pragmatic, prospective, single-arm, multi-center, observational registry will evaluate the safety and effectiveness of PFA for the treatment of atrial fibrillation in underrepresented minority patients using FDA approved Boston Scientific PFA catheters; all data collected will be standard of care.

Conditions

Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Keywords

Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Pulsed Field Ablation

Outcome Measures

Primary Outcomes (2)

• Composite Serious Adverse Events

  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.

  up to Day 60 Post Procedure

• Chronic Treatment Success

  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

  12 Months

Study Arms (1)

Patients indicated for atrial arrhythmia ablation

All patients will receive standard of care treatment.

Device: FARAWAVE Pulsed Field Ablation Catheter

Interventions

FARAWAVE Pulsed Field Ablation Catheter DEVICE

The FARAWAVE Pulsed Field Ablation (PFA) Catheter is a component of the FARAPULSE PFA System. The FARAWAVE Catheter is an over-the-wire, multi-electrode catheter designed to deliver PFA energy to the distal section for cardiac ablation. The FARAWAVE Catheter is indicated for: 1) the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF) 2) the isolation of pulmonary veins and the posterior wall in the treatment of drug-refractory, symptomatic Persistent Atrial Fibrillation (episode duration less than one year) This device is FDA approved.

Patients indicated for atrial arrhythmia ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Racial or ethnic minorities defined based on modified National Institutes of Health (NIH) categories: Black or African American, American Indian/Alaska native, Asian, Hawaiian or other Pacific Islander, multiracial or of Hispanic, Latino/Latina origin.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vivek Reddy: lead
• Boston Scientific Corporation: collaborator

Study Sites (2)

The Mount Sinai Hospital

New York, New York, 10030, United States

RECRUITING

Valley Health System

Winchester, Virginia, 22601, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Devin Chamberlain

CONTACT

(646) 984-1049; devin.chamberlain@mountsinai.org

Betsy Ellsworth, MSN, ANP

CONTACT

Betsy.ellsworth@mountsinai.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Cardiac Arrhythmia Service

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 17, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)