A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF
DISRUPT-AF
1 other identifier
observational
10,000
1 country
25
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
Typical duration for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2024
CompletedFirst Posted
Study publicly available on registry
March 28, 2024
CompletedStudy Start
First participant enrolled
April 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2027
October 31, 2025
October 1, 2025
2.6 years
March 21, 2024
October 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Long term effectiveness
Freedom from atrial arrhythmia recurrence post 90-day blanking period
12 months
Long-term safety
Rate of long-term safety events defined as procedure or device related reportable events (complications) that occur greater than 30 days post ablation. Data for this endpoint will be evaluated from the pooled results of the SMO and FM study arms.
12 months
Study Arms (3)
Acute Arm
Data will be collected at pre-ablation/baseline and at time of the ablation procedure. Sites should follow the subjects per their standard of care and at a minimum report any acute onset procedure or device-related complications through 30-days post procedure. Data collection will include procedural workflow, procedural outcomes, and acute onset procedure or device-related complications through 30 days.
Symptomatic Monitoring Only Arm (SMO)
Data will be collected at pre-ablation/baseline, the ablation procedure, a 3-Month post-ablation office visit and 12-Months post-ablation (monitoring is triggered for symptomatic recurrences only). Data collection will include procedural workflow, procedural outcomes, acute, mid, and late onset procedure or device related complications, and symptomatic recurrence.
Full Monitoring Arm (FM)
Data will be collected at pre-ablation/baseline, the ablation procedure, a 3-Month post-ablation office visit, interim continuous monitoring for asymptomatic arrhythmia recurrence at 6- and 12-Months post-ablation as well as monitoring as needed for symptomatic recurrences, and a 12-Month post-ablation office visit. Data collection will include procedural workflow, procedural outcomes, acute, mid, and late onset procedure or device related complications, symptomatic recurrence as well as asymptomatic recurrence.
Interventions
Ablation using the Boston Scientific Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF)
Eligibility Criteria
Patients presenting at participating sites for atrial fibrillation ablation that meet all inclusion criteria.
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
- De Novo ablation unless it is a repeat procedure for a subject whose index procedure is also included in the registry
- 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
- Prior left atrial ablation (catheter or surgical)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Arrhythmia Institute at Grandview
Birmingham, Alabama, 35243, United States
Arrhythmia Research Group
Jonesboro, Arkansas, 72401, United States
Community Memorial Health Systems
Ventura, California, 93003, United States
The Arrythmia Center of South Florida
Delray Beach, Florida, 33484, United States
Ascension St. Vincent's
Jacksonville, Florida, 32204, United States
HCA Florida Mercy Hospital
Miami, Florida, 33133, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Endeavor Health (Northshore)
Glenview, Illinois, 60026, United States
Ascension St Vincent -Indianapolis Ascension Healt
Indianapolis, Indiana, 46184, United States
MercyOne Iowa Heart Center
West Des Moines, Iowa, 50026, United States
Norton Heart & Vascular Institute
Louisville, Kentucky, 40205, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey, 08035, United States
HCA Research Institute Mission Hospital
Asheville, North Carolina, 28801, United States
The Christ Hospital - Heart & Vascular
Cincinnati, Ohio, 45219, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
OhioHealth Research Institute
Columbus, Ohio, 43214, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
WellSpan Health
York, Pennsylvania, 17402, United States
HCA - Trident Medical Center
North Charleston, South Carolina, 29406, United States
Ascension St. Thomas Nashville
Nashville, Tennessee, 37203, United States
Ascension Texas Cardiovascular
Austin, Texas, 78705, United States
Texas Cardiac Arrhythmia Research Foundation (St. Davids)
Austin, Texas, 78705, United States
St. Mark's Hospital
Salt Lake City, Utah, 84124, United States
HCA Research Institute - Chippenham Hospital
Richmond, Virginia, 23225, United States
Related Publications (1)
Al-Ahmad A, Osorio J, Day J, Wasserlauf J, Nair D, Eckart R, Campbell D, Dukes J, Cuoco F, Costello J, Zagrodzky J, Kessler D, Morales G, Rajendra A, Oza S, Barakat A, Magnano A, Amin A, Silverstein J, Thosani A, Bezenek SM, Zei P, Dai C, Natale A, Horton R; DISRUPT AF Investigators. Patient and Procedural Factors Associated With Same-Day Discharge Following Pulsed Field Ablation for Atrial Fibrillation: Insights From the DISRUPT-AF Registry. J Cardiovasc Electrophysiol. 2026 Jan;37(1):149-156. doi: 10.1111/jce.70210. Epub 2025 Dec 2.
PMID: 41331670DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2024
First Posted
March 28, 2024
Study Start
April 24, 2024
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
January 30, 2027
Last Updated
October 31, 2025
Record last verified: 2025-10