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The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
NCT04612244 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 706 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04612244 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, New York, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04612244?
The interventions under investigation include: FARAPULSE Pulsed Field Ablation System (DEVICE), RadioFrequency and Cryoballoon Ablation (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04612244?
This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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