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RECRUITING
NCT06765356
PHASE4

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

Sponsor: Vivek Reddy

View on ClinicalTrials.gov

Summary

The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the FARAPULSE catheter system (FARAWAVE catheter used in combination with the FARASTAR generator), to treat patients with atrial fibrillation during clinically-indicated ablation procedures

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

275

Start Date

2025-04-15

Completion Date

2027-03-30

Last Updated

2025-11-26

Healthy Volunteers

No

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.

Locations (5)

Arrhythmia Research Group

Jonesboro, Arkansas, United States

Naples Comprehensive Health

Naples, Florida, United States

The Mount Sinai Hospital

New York, New York, United States

UPMC Pinnacle Hospitals

Harrisburg, Pennsylvania, United States

Trident Medical Center

North Charleston, South Carolina, United States