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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04612244
The ClinicalTrials.gov registry entry for NCT04612244 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 706 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 830-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (15% lower). The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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