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The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.
The objective of ADVENT PAS is to evaluate the long-term safety and effectiveness profile of the FARAPULSE Pulsed Field Ablation System when used to perform pulmonary vein isolation (PVI) in the de-novo ablation treatment of patients with paroxysmal atrial fibrillation (PAF).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FARAPULSE™ Pulsed Field Ablation System | Device | De-novo pulmonary vein isolation (PVI) will be performed with the FARAPULSE Pulsed Field Ablation (PFA) System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite incidence of patients with procedure-related and device-related serious adverse events at 7-Days and 12-months post-Index Procedure. |
| 12 Months |
| Treatment success, defined as the incidence of subjects with successful isolation of clinically relevant pulmonary veins AND patients without recurrence or interventions for AF, AFL, AT after the blanking period through 12 months. | - Acute Procedural Success: Acute procedural success is defined as isolation of all clinically relevant pulmonary veins or anatomical equivalents using the FARAPULSE Pulsed Field Ablation System only AND - Chronic Success, defined as freedom from the following: After the Blanking Period up to the 12-Month Follow-up visit:
| 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a de-novo pulmonary vein isolation ablation with the FARAPULSE Pulsed Field Ablation (PFA) System.
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| Name | Affiliation | Role |
|---|---|---|
| Stavros E Mountantonakis, MD, MBA | Northwell Health, Lenox Hill Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Infirmary Medical Center | Mobile | Alabama | 36608 | United States | ||
| Scottsdale Healthcare - Shea |
No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html
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| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Alta Bates Summit Medical Center | Oakland | California | 94609 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Florida Heart Rhythm Specialists, PLLC | Fort Lauderdale | Florida | 33308 | United States |
| Baptist Medical Center | Jacksonville | Florida | 32207 | United States |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | United States |
| AdventHealth Tampa | Tampa | Florida | 33613 | United States |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4504 | United States |
| New York Hospital Queens | Flushing | New York | 11355 | United States |
| Columbia University Medical Center | New York | New York | 10019 | United States |
| Northwell Health | New York | New York | 10075 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| East Carolina University Medical Center | Greenville | North Carolina | 27834 | United States |
| Pinnacle Health at Harrisburg Hospital | Harrisburg | Pennsylvania | 17104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Prisma Health Richland Hospital | Columbia | South Carolina | 29203 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0737 | United States |
| University of Texas Houston Health Science Center | Houston | Texas | 77030 | United States |
| Orion Medical | Houston | Texas | 77034 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Sos Cardio Servicoshospitalares Ltda | Florianópolis | Santa Catarina | 88030-000 | Brazil |
| Instituto do Coração do HCFMUSP | São Paulo | São Paulo | 05403-900 | Brazil |
| Institut de Cardiologie de Montreal-Hospital | Montreal | Quebec | H1T 1C8 | Canada |
| Institut universitaire de Cardiologie et de Pneumologie de Quebec | Québec | Quebec | G1V 4G5 | Canada |
| Hospital Regional de Concepcion | Concepción | Biobio | 4070022 | Chile |
| 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 |
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