275
Participants
Start Date
April 15, 2025
Primary Completion Date
March 30, 2027
Study Completion Date
March 30, 2027
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.
RECRUITING
The Mount Sinai Hospital, New York
RECRUITING
Trident Medical Center, North Charleston
Collaborators (1)
Boston Scientific Corporation
INDUSTRY
Vivek Reddy
OTHER