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NCT04612244 · ClinicalTrials.gov registry record · NA
The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
A NA study of Paroxysmal Atrial Fibrillation, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 706
- Enrollment target
- 20
- Study locations
NCT04612244: Completed NA study of Paroxysmal Atrial Fibrillation, sponsored by Boston Scientific Corporation.
NCT04612244 is a NA study of Paroxysmal Atrial Fibrillation that has completed, run by Boston Scientific Corporation. The registered enrollment target is 706 participants, below the 830-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04612244, a NA study of Paroxysmal Atrial Fibrillation, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 706 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEs
Conditions Studied
Interventions
- DEVICE FARAPULSE Pulsed Field Ablation System
- DEVICE RadioFrequency and Cryoballoon Ablation
Study Locations (20)
California
- Scripps Memorial Hospital La Jolla - La Jolla
- California Pacific Medical Center - San Francisco
- University of California San Francisco (UCSF) - San Francisco
New York
- NYU Langone Health_Heart Rhythm Center - New York
- Mount Sinai, Icahn School of Medicine - New York
- Northwell Health- Lenox Hill Hospital - New York
Alabama
- Grandview Medical Center - Birmingham
- The University of Alabama at Birmingham - Birmingham
Arizona
- Banner University Medical Center - Phoenix
- HonorHealth Scottsdale Shea - Scottsdale
Massachusetts
- Massachusetts General Hospital (MGH) - Boston
- Beth Israel Deaconess Medical Center - Boston
Georgia
- Emory University Hospital - Atlanta
Idaho
- St Luke's Regional Medical Center - Boise
Maryland
- Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 706 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2023-05-15 |
| Phase | NA |
What the finished NCT04612244 record still lists
NCT04612244 is an interventional study that assigns participants to a tested intervention. The registered 706 participants enrollment target is mid-sized for trials with a published cap, below the 830-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (15% lower).
The record links to 1 condition, with Paroxysmal Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which FARAPULSE Pulsed Field Ablation System is the first listed.
NCT04612244 names 20 study sites across 13 states, led by California, New York, Alabama.
Frequently Asked Questions
What is clinical trial NCT04612244 about?
NCT04612244 is a clinical study titled "The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation". 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.
What is the current status of trial NCT04612244?
This trial is currently completed. It is a NA study. The enrollment target is 706 participants. The study started on 2021-03-01. Estimated completion is 2023-05-15.
What conditions does trial NCT04612244 study?
This clinical trial studies the following conditions: Paroxysmal Atrial Fibrillation.
What interventions are being tested in trial NCT04612244?
The interventions under investigation include: FARAPULSE Pulsed Field Ablation System (DEVICE), RadioFrequency and Cryoballoon Ablation (DEVICE).
Who is sponsoring clinical trial NCT04612244?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04612244 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04612244's enrollment target sits among peer trials
706 2nd of 24 the highest of 24 other Paroxysmal Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Paroxysmal Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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