Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias

PHASE4RecruitingINTERVENTIONAL
Enrollment

275

Participants

Timeline

Start Date

April 15, 2025

Primary Completion Date

March 30, 2027

Study Completion Date

March 30, 2027

Conditions
Persistent Atrial FibrillationParoxysmal Atrial FibrillationLong-standing Persistent Atrial Fibrillation
Interventions
DEVICE

Farapulse Catheter System

"The FARAWAVE PFA Catheter is a sterile, single use, over-the-wire, non-deflectable device that is used with the FARASTAR Catheter Connection Cable and FARASTAR Generator to enable delivery of Pulsed Field Ablation energy for irreversible electroporation. The FARAWAVE PFA Catheter has five (5) variably deployable splines. The five splines are undeployed during insertion and removal and during use can deploy continuously from an undeployed state through a partially deployed (basket-shaped) configuration to a fully deployed (flower-shaped) configuration with five petals."

DRUG

Low-dose Colchicine

For participants in the colchicine sub-study, 0.3 mg BID Colchicine. Colchicine will be prescribed to the patient starting 5 days prior to ablation. Patient will continue the colchicine for 3 weeks post-ablation.

Trial Locations (2)

10029

RECRUITING

The Mount Sinai Hospital, New York

29406

RECRUITING

Trident Medical Center, North Charleston

Sponsors
All Listed Sponsors
collaborator

Boston Scientific Corporation

INDUSTRY

lead

Vivek Reddy

OTHER