The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
Completed · Not applicable
Conditions studied: Paroxysmal Atrial Fibrillation
In brief
This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon catheters indicated for the treatment of PAF.
Key facts
- Study ID
- NCT04612244
- Run by
- Boston Scientific Corporation
- People needed
- 706
- Starts
- 2021-03-01
- Expected to finish
- 2023-05-15
- Last updated by the study team
- 2024-11-20
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Grandview Medical Center — Birmingham, Alabama, United States
- The University of Alabama at Birmingham — Birmingham, Alabama, United States
- Banner University Medical Center — Phoenix, Arizona, United States
- HonorHealth Scottsdale Shea — Scottsdale, Arizona, United States
- Scripps Memorial Hospital La Jolla — La Jolla, California, United States
- California Pacific Medical Center — San Francisco, California, United States
- University of California San Francisco (UCSF) — San Francisco, California, United States
- Emory University Hospital — Atlanta, Georgia, United States
- St Luke's Regional Medical Center — Boise, Idaho, United States
- Johns Hopkins — Baltimore, Maryland, United States
- Massachusetts General Hospital (MGH) — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
- Nebraska Methodist Health system, Inc — Omaha, Nebraska, United States
- Catholic Medical Center — Manchester, New Hampshire, United States
- Hackensack University Medical Center/Hackensack Meridian Health — Hackensack, New Jersey, United States
- NYU Langone Health_Heart Rhythm Center — New York, New York, United States
- Mount Sinai, Icahn School of Medicine — New York, New York, United States
- Northwell Health- Lenox Hill Hospital — New York, New York, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Providence St Vincent Medical Center, Heart and Vascular Clinical Trials — Portland, Oregon, United States
- Doylestown Hospital — Doylestown, Pennsylvania, United States
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
- UPMC Pinnacle Health Cardiovascular Institute Inc. — Wormleysburg, Pennsylvania, United States
Full record on ClinicalTrials.gov
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