The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
Public ClinicalTrials.gov record NCT04612244. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective Randomized Pivotal Trial of the FARAPULSE Pulsed Field Ablation System Compared With Standard of Care Ablation in Patients With Paroxysmal Atrial Fibrillation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04612244
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 706 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 1, 2021 (Actual)
- Primary completion
- May 15, 2023 (Actual)
- Completion
- May 15, 2023 (Actual)
- Last update posted
- Nov 20, 2024
2021 – 2023
United States locations
- U.S. sites
- 34
- U.S. states
- 20
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Grandview Medical Center | Birmingham | Alabama | 35243 | — |
| The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Banner University Medical Center | Phoenix | Arizona | 85006 | — |
| HonorHealth Scottsdale Shea | Scottsdale | Arizona | 85258 | — |
| Scripps Memorial Hospital La Jolla | La Jolla | California | 92037 | — |
| California Pacific Medical Center | San Francisco | California | 94109 | — |
| University of California San Francisco (UCSF) | San Francisco | California | 94143 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| St Luke's Regional Medical Center | Boise | Idaho | 83712 | — |
| Johns Hopkins | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital (MGH) | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| Nebraska Methodist Health system, Inc | Omaha | Nebraska | 68114 | — |
| Catholic Medical Center | Manchester | New Hampshire | 03102 | — |
| Hackensack University Medical Center/Hackensack Meridian Health | Hackensack | New Jersey | 07601 | — |
| NYU Langone Health_Heart Rhythm Center | New York | New York | 10016 | — |
| Mount Sinai, Icahn School of Medicine | New York | New York | 10029 | — |
| Northwell Health- Lenox Hill Hospital | New York | New York | 10075 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Providence St Vincent Medical Center, Heart and Vascular Clinical Trials | Portland | Oregon | 97225 | — |
| Doylestown Hospital | Doylestown | Pennsylvania | 18901 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| UPMC Pinnacle Health Cardiovascular Institute Inc. | Wormleysburg | Pennsylvania | 17105 | — |
| Trident Medical Center | Charleston | South Carolina | 29406 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Saint Thomas Heart at Baptist Hospital | Nashville | Tennessee | 37205 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| St Davids_Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22903 | — |
| Virginia Commonwealth University Health System | Richmond | Virginia | 23298 | — |
| MedStar Washington Hospital Center | Northwest | Washington | 20010 | — |
| Swedish Medical Center Heart & Vascular Research | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04612244, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 20, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04612244 live on ClinicalTrials.gov.