REPRESENT-PF Registry (REPRESENT-PF)

April 9, 2026 updated by: Vivek Reddy

Prospective Multicenter Registry on the Clinical Outcomes and Safety of PFA for Atrial Fibrillation in Underrepresented Minorities (REPRESENT-PF Registry)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Catheter ablation is an established treatment for atrial fibrillation (AF) and is increasingly being utilized as first line therapy in patients with symptomatic AF. Pulsed field ablation (PFA) is a novel transformative technology that has demonstrated an excellent safety profile owing to its ability to achieve preferential myocardial tissue ablation and improve workflow efficiencies while exhibiting at least comparable efficacy to conventional thermal ablation modalities. This development has significant public health implications given the increasing prevalence of AF with associated morbidity and mortality.

Historically, Blacks, Hispanics, Asians and other racial and ethnic minorities have been underrepresented in clinical trials on the management of AF and specifically catheter ablation. This is further compounded by the fact that racial and ethnic minorities experience higher rates of AF-related adverse events as compared to non-minorities while being significantly less likely to receive catheter ablation therapy.

A multitude of factors have been identified as potential contributors to both the reduced utilization of catheter ablation therapy for under-represented minorities, and the increased event rates. The significant paucity of data limits more in depth analysis. It is therefore evident that greater strides towards inclusivity are needed to expand upon the clinical evidence with hopes of improving care delivery to this population.

REPRESENT-PF is a pragmatic, prospective single-arm, multi-center, observational registry studying the safety and effectiveness of PFA in underrepresented minority patients indicated for atrial arrhythmia ablation performed with Boston Scientific FDA approved catheters. The study will include both paroxysmal and persistent patients with a 1- year follow up period.

Racial or ethnic minorities will be defined based on a 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.

Study Type

Observational

Enrollment (Estimated)

275

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10030
        • Recruiting
        • The Mount Sinai Hospital
        • Contact:
        • Principal Investigator:
          • Joshua Lampert, MD
    • Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients indicated for atrial arrhythmia ablation
All patients will receive standard of care treatment.
Device: FARAWAVE Pulsed Field Ablation Catheter
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Serious Adverse Events
Time Frame: up 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.
up to Day 60 Post Procedure
Chronic Treatment Success
Time Frame: 12 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
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vivek Reddy

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Vivek Reddy, MD, ICAHN School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY-25-01408

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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