A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF
NCT ID: NCT06335082
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
10000 participants
OBSERVATIONAL
2024-04-24
2027-01-30
Brief Summary
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Detailed Description
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The registry has three cohorts: 1) Acute Arm, 2) Symptomatic Monitoring Only Arm, and 3) Full Monitoring Arm. In the Acute Arm, patient assessments will occur at pre- procedure and procedure visits. In both the Symptomatic Monitoring Only Arm and the Full Monitoring Arm, patient assessments will occur at pre- procedure, procedure, 3 months, and 1 year post ablation. Additionally, the Full Monitoring Arm will assess for asymptomatic recurrence at 6- and 12-months post-ablation.
Sites will be assigned to an arm in which they will enroll under based on their practices current Standard of Care. Sites can only participate in one arm.
The primary purpose of the registry is to assess clinical outcomes, including procedural efficiency, safety, and long-term effectiveness of pulsed field ablation (PFA) in the treatment of patients with AF. Also, to assess the effect of PFA technology implementation on practice patterns, operational workflow and operator experience.
The registry will utilize real world clinical data obtained from the use of commercially available technologies under the authority of a health care practitioner within a legitimate practitioner-patient relationship.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Pulsed Field Ablation
Ablation using the Boston Scientific Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF)
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.
Pulsed Field Ablation
Ablation using the Boston Scientific Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF)
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.
Pulsed Field Ablation
Ablation using the Boston Scientific Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF)
Interventions
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Pulsed Field Ablation
Ablation using the Boston Scientific Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF)
Eligibility Criteria
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Inclusion Criteria
* 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
* 18 years of age or older
* Able and willing to participate in baseline and follow up evaluations for the full length of the registry
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Heart Rhythm Clinical and Research Solutions, LLC
OTHER
Responsible Party
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Locations
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Arrhythmia Institute at Grandview
Birmingham, Alabama, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Community Memorial Health Systems
Ventura, California, 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
Endeavor Health (Northshore)
Glenview, Illinois, United States
Ascension St Vincent -Indianapolis Ascension Healt
Indianapolis, Indiana, 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
Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey, United States
HCA Research Institute Mission Hospital
Asheville, North Carolina, United States
The Christ Hospital - Heart & Vascular
Cincinnati, Ohio, United States
The Christ Hospital
Cincinnati, Ohio, United States
OhioHealth Research Institute
Columbus, Ohio, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
WellSpan Health
York, Pennsylvania, United States
HCA - Trident Medical Center
North Charleston, South Carolina, United States
Ascension St. Thomas Nashville
Nashville, Tennessee, United States
Ascension Texas Cardiovascular
Austin, Texas, United States
Texas Cardiac Arrhythmia Research Foundation (St. Davids)
Austin, Texas, United States
St. Mark's Hospital
Salt Lake City, Utah, United States
HCA Research Institute - Chippenham Hospital
Richmond, Virginia, United States
Countries
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Other Identifiers
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DISRUPT-AF
Identifier Type: -
Identifier Source: org_study_id
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