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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.
Official title: Prospective Multicenter Registry on the Clinical Outcomes and Safety of PFA for Atrial Fibrillation in Underrepresented Minorities (REPRESENT-PF Registry)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
275
Start Date
2026-03-30
Completion Date
2028-03-01
Last Updated
2026-04-17
Healthy Volunteers
No
Interventions
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.
Locations (2)
The Mount Sinai Hospital
New York, New York, United States
Valley Health System
Winchester, Virginia, United States