Completed
NA
INTERVENTIONAL
NCT04612244
The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
Interventions
Name:
FARAPULSE Pulsed Field Ablation System
Type:
DEVICE
Description:
Ablation using the FARAPULSE Pulsed Field Ablation System
Name:
RadioFrequency and Cryoballoon Ablation
Type:
DEVICE
Description:
Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation
Primary Outcomes
Measure:
Composite Safety Endpoint;Proportion of MITT Subjects With One or More of the Specified Device or Procedure Related SAEs
TimeFrame:
7 days and 12 Months
Description:
Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEs
Measure:
Primary Effectiveness Endpoint
TimeFrame:
12-Months
Description:
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).
Trial Information
NCT ID
NCT04612244
Status
Completed
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
Boston Scientific Corporation
Last Updated
December 15, 2025