The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
- Conditions
- Paroxysmal Atrial Fibrillation
- Interventions
- Device: RadioFrequency and Cryoballoon AblationDevice: FARAPULSE Pulsed Field Ablation System
- Registration Number
- NCT04612244
- Lead Sponsor
- Farapulse, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 706
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Force Sensing Radiofrequency Ablation and Cryoballoon Ablation RadioFrequency and Cryoballoon Ablation - FARAPULSE Pulsed Field Ablation System FARAPULSE Pulsed Field Ablation System -
- Primary Outcome Measures
Name Time Method Composite Safety Endpoint;Proportion of MITT Subjects With One or More of the Specified Device or Procedure Related SAEs 7 days and 12 Months Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEs
Primary Effectiveness Endpoint 12-Months Treatment Success: The primary effectiveness endpoint is Treatment Success in MITT Subjects, defined as:
1. Acute Procedural Success AND
2. Chronic Success, defined as freedom from:
1. At the Index / Rescheduled Index Procedure: Use of a non-randomized treatment modality for PVI
2. After the Blanking Period:
i. Occurrence of any Detectable AF, AFL or AT (excluding CTI-dependent flutter confirmed by EP study)
ii. Any cardioversion for AF, AFL or AT (excluding for CTI-dependent flutter)
iii. Use of any Type I or Type III antiarrhythmic medication for the treatment of AF, AFL or AT
c. At any time:
i. Re-ablation for AF, AFL or AT (other than for CTI-dependent flutter)
ii. Use of amiodarone, except intra-procedurally to control an arrhythmia Endpoint status will be assessed through the Month 12 Assessment (Day 360 ± 30).
- Secondary Outcome Measures
Name Time Method Change in PV Cross-sectional Area 3 months Mean change in aggregate PV Cross-Sectional area (cm\^2) from baseline to Day 90
Primary Effectiveness Treatment Success Tested for Superiority 12 Months The secondary effectiveness endpoint is the same as the primary effectiveness endpoint but will be tested for superiority rather than non-inferiority. The proportion of Pulsed Field Subjects with Treatment Success will be assessed for superiority to the proportion of Thermal Subjects with Treatment Success.
Trial Locations
- Locations (34)
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of California San Francisco (UCSF)
🇺🇸San Francisco, California, United States
Saint Thomas Heart at Baptist Hospital
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Banner University Medical Center
🇺🇸Phoenix, Arizona, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Grandview Medical Center
🇺🇸Birmingham, Alabama, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
HonorHealth Scottsdale Shea
🇺🇸Scottsdale, Arizona, United States
Scripps Memorial Hospital La Jolla
🇺🇸La Jolla, California, United States
St Luke's Regional Medical Center
🇺🇸Boise, Idaho, United States
Massachusetts General Hospital (MGH)
🇺🇸Boston, Massachusetts, United States
Nebraska Methodist Health system, Inc
🇺🇸Omaha, Nebraska, United States
Hackensack University Medical Center/Hackensack Meridian Health
🇺🇸Hackensack, New Jersey, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Catholic Medical Center
🇺🇸Manchester, New Hampshire, 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
Providence St Vincent Medical Center, Heart and Vascular Clinical Trials
🇺🇸Portland, Oregon, United States
UPMC Pinnacle Health Cardiovascular Institute Inc.
🇺🇸Wormleysburg, Pennsylvania, United States
Penn Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
St Davids_Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
Trident Medical Center
🇺🇸Charleston, South Carolina, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Virginia Commonwealth University Health System
🇺🇸Richmond, Virginia, United States
Swedish Medical Center Heart & Vascular Research
🇺🇸Seattle, Washington, United States
MedStar Washington Hospital Center
🇺🇸Northwest, Washington, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States