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Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias
Sponsor: Vivek Reddy
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
Conditions
Interventions
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.
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