A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF
- Conditions
- Atrial Fibrillation
- Interventions
- Device: Pulsed Field Ablation
- Registration Number
- NCT06335082
- 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).
- Detailed Description
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). All types of AF including paroxysmal, persistent and long standing persistent may be included.
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 900
- 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
- 18 years of age or older
- Able and willing to participate in baseline and follow up evaluations for the full length of the registry
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Acute Arm Pulsed Field Ablation 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) Pulsed Field Ablation 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) Pulsed Field Ablation 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.
- Primary Outcome Measures
Name Time Method Long term effectiveness 12 months Freedom from atrial arrhythmia recurrence post 90-day blanking period
Long-term safety 12 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Ascension Texas Cardiovascular
🇺🇸Austin, Texas, 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
Ascension St Vincent -Indianapolis Ascension Healt
🇺🇸Indianapolis, Indiana, United States
Norton Heart & Vascular Institute
🇺🇸Louisville, Kentucky, United States
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
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Endeavor Health (Northshore)
🇺🇸Glenview, Illinois, United States
Cardiovascular Associates of Delaware Valley
🇺🇸Haddon Heights, New Jersey, United States
Texas Cardiac Arrhythmia Research Foundation (St. Davids)
🇺🇸Austin, Texas, United States
St. Mark's Hospital
🇺🇸Salt Lake City, Utah, United States
MercyOne Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
HCA Research Institute Mission Hospital
🇺🇸Asheville, North Carolina, United States
HCA - Trident Medical Center
🇺🇸North Charleston, South Carolina, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
WellSpan Health
🇺🇸York, Pennsylvania, United States
HCA Research Institute - Chippenham Hospital
🇺🇸Richmond, Virginia, United States