407
Participants
Start Date
June 3, 2025
Primary Completion Date
April 30, 2027
Study Completion Date
January 31, 2028
FARAPULSE™ Pulsed Field Ablation System
"The FARAPULSE™ Pulsed Field Ablation System is indicated for the treatment of symptomatic atrial fibrillation.~The FARAWAVE Catheter is indicated for the isolation of pulmonary veins and posterior wall in the treatment of drug-refractory, recurrent, symptomatic paroxysmal and persistent atrial fibrillation. The FARAWAVE Catheter is also indicated for the for the isolation of pulmonary veins and posterior wall in the treatment of persistent atrial fibrillation as an alternative to anti-arrhythmic drug (AAD) therapy as an initial rhythm control strategy.~The FARAPOINT™ PFA Catheter is indicated for use as an adjunctive device for 1) the creation of an ablation line between the inferior vena cava and the tricuspid valve and/or 2) Mitral Isthmus, when the FARAWAVE Catheter is used in the endocardial treatment of persistent atrial fibrillation (episode duration no greater than 12 months)."
RECRUITING
Johns Hopkins Hospital, Baltimore
RECRUITING
Trident Medical Center, Charleston
RECRUITING
Emory University Hospital, Atlanta
RECRUITING
Memorial Health University Medical Center, Savannah
RECRUITING
HCA Florida Mercy Hospital, Miami
RECRUITING
Mobile Infirmary Medical Center, Mobile
RECRUITING
Ohio State University Medical Center, Columbus
RECRUITING
Arrhythmia Research Group-Research Facility, Jonesboro
RECRUITING
Christus Trinity Mother Frances Health System, Tyler
RECRUITING
Massachusetts General Hospital, Boston
RECRUITING
Virtua Health Inc., Marlton
RECRUITING
National Taiwan University Hospital, Taipei
RECRUITING
Taipei Veterans General Hospital, Taipei
Lead Sponsor
Boston Scientific Corporation
INDUSTRY