At a glance
ClinicalIndex Comparison RecordN/ACompleted· 706 enrolled
Drug / intervention
FARAPULSE Pulsed Field Ablation System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Randomized Pivotal Trial of the FARAPULSE Pulsed Field Ablation System Compared With Standard of Care Ablation in Patients With Paroxysmal Atrial Fibrillation
In Brief
A clinical study evaluating FARAPULSE Pulsed Field Ablation System and RadioFrequency and Cryoballoon Ablation for Paroxysmal Atrial Fibrillation. Completed, enrolled 706 participants across 34 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Atrial Fibrillation
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartMar 2021
Primary CompletionMay 2023
TodayJul 2026
First PostedNov 2, 2020
Enrollment StartMar 1, 2021
Primary CompletionMay 15, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.7 years ago
Interventions
FARAPULSE Pulsed Field Ablation Systemdevice
Ablation using the FARAPULSE Pulsed Field Ablation System
RadioFrequency and Cryoballoon Ablationdevice
Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation