REPRESENT-PF Registry

Part of paid clinical trials in New York, New York.

Sponsor
Vivek Reddy
Study ID
NCT07535268
Status
Recruiting
Apply to this trial

Conditions

  • Paroxysmal Atrial Fibrillation
  • Persistent Atrial Fibrillation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 30, 2026
Status verified
Apr 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
275 participants (estimated)

Arms

  • Arm: Patients indicated for atrial arrhythmia ablation
    All patients will receive standard of care treatment.

Primary Outcome Measure

Composite Serious Adverse Events [ Time Frame: up to Day 60 Post Procedure ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Mount Sinai HospitalNew YorkNew York10030
Devin Chamberlain
[email protected]
(646) 984-1049
Joshua Lampert, MD (PRINCIPAL_INVESTIGATOR)
Valley Health SystemWinchesterVirginia22601
Lauren Peterson
[email protected]

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The Mount Sinai Hospital· New York, NYValley Health System· Winchester, VA

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