A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF

Enrolling by invitation

Conditions studied: Atrial Fibrillation

In brief

The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF).

Key facts

Study ID

NCT06335082

Run by

Heart Rhythm Clinical and Research Solutions, LLC

People needed

10000

Starts

2024-04-24

Expected to finish

2028-01-30

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who, in the opinion of the Investigator, are candidates for ablation for AF
• Plans to undergo an ablation procedure using the FARAPULSE Pulsed Field Ablation System manufactured by Boston Scientific (as of July 1, 2026, patients enrolled must have procedures completed using the OPAL HDx mapping system, unless the subject is participating in a sub-study not requiring OPAL usage)
• De Novo or repeat procedure using the FARAPULSE Pulse Field Ablation System.
• 18 years of age or older
• Able and willing to participate in baseline and follow up evaluations for the full length of the registry

You may not qualify if…

• Enrolled in an investigational drug or device trial, or any trial that dictates the treatment plan without prior approval from Sponsor
• Currently receiving inotropic or mechanical support for Stage IV congestive heart failure, cardiogenic and/or septic shock.
• In the opinion of the Investigator, any known contraindication to an ablation procedure or to any device or drug required for use during an ablation procedure as assessed by the Investigator

Where it is running

• Arrhythmia Institute at Grandview — Birmingham, Alabama, United States
• Arrhythmia Research Group — Jonesboro, Arkansas, United States
• Sutter Health - California Pacific Medical Center — San Francisco, California, United States
• Community Memorial Health Systems — Ventura, California, United States
• South Denver Cardiology Associates — Littleton, Colorado, United States
• The Arrythmia Center of South Florida — Delray Beach, Florida, United States
• Ascension St. Vincent's — Jacksonville, Florida, United States
• HCA Florida Mercy Hospital — Miami, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• St. Luke's Medical Center — Boise, Idaho, United States
• Endeavor Health (Northshore) — Glenview, Illinois, United States
• Ascension St Vincent -Indianapolis Ascension Health — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• MercyOne Iowa Heart Center — West Des Moines, Iowa, United States
• Norton Heart & Vascular Institute — Louisville, Kentucky, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• The Heart Rhythm Center of Mississippi — Gulfport, Mississippi, United States
• Cardiovascular Associates of Delaware Valley — Haddon Heights, New Jersey, United States
• The Valley Hospital — Paramus, New Jersey, United States
• HCA Research Institute Mission Hospital — Asheville, North Carolina, United States
• East Carolina University — Greenville, North Carolina, United States
• The Christ Hospital - Heart & Vascular — Cincinnati, Ohio, United States
• OhioHealth Research Institute — Columbus, Ohio, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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