RecruitingNCT07535268

REPRESENT-PF Registry

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

Sponsor

Vivek Reddy

Enrollment

275 participants

Start Date

Mar 30, 2026

Study Type

OBSERVATIONAL

Conditions

Persistent Atrial Fibrillation Paroxysmal Atrial Fibrillation

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria4

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEFARAWAVE 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.