Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Field Ablation | Device | Ablation using the Boston Scientific Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients presenting at participating sites for atrial fibrillation ablation that meet all inclusion criteria.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrhythmia Institute at Grandview | Birmingham | Alabama | 35243 | United States | ||
| Arrhythmia Research Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41331670 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Sutter Health - California Pacific Medical Center | San Francisco | California | 94109 | United States |
| Community Memorial Health Systems | Ventura | California | 93003 | United States |
| South Denver Cardiology Associates | Littleton | Colorado | 80120 | 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 |
| St. Luke's Medical Center | Boise | Idaho | 83712 | United States |
| Endeavor Health (Northshore) | Glenview | Illinois | 60026 | United States |
| Ascension St Vincent -Indianapolis Ascension Health | Indianapolis | Indiana | 46184 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | 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 |
| The Heart Rhythm Center of Mississippi | Gulfport | Mississippi | 39502 | United States |
| Cardiovascular Associates of Delaware Valley | Haddon Heights | New Jersey | 08035 | United States |
| The Valley Hospital | Paramus | New Jersey | 07652 | United States |
| HCA Research Institute Mission Hospital | Asheville | North Carolina | 28801 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Novant Health Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| The Christ Hospital - Heart & Vascular | Cincinnati | Ohio | 45219 | United States |
| OhioHealth Research Institute | Columbus | Ohio | 43214 | United States |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | 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 |
| HCA Medical City Dallas | Dallas | Texas | 75243 | United States |
| CHRISTUS Trinity Mother Frances Health System | Tyler | Texas | 75701 | United States |
| St. Mark's Hospital | Salt Lake City | Utah | 84124 | United States |
| HCA Research Institute - Chippenham Hospital | Richmond | Virginia | 23225 | United States |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided