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The (ADVENT LTO) is an observational, non-significant risk study to assess the progression of atrial fibrillation in subjects who received ablation treatment with either the FARAPULSE Pulsed Field Ablation System or thermal ablation in the ADVENT Trial.
This study is an observational, non-significant risk study. Subjects who participated in the FARAPULSE ADVENT Trial (NCT04612244) will be approached for participation.
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| Measure | Description | Time Frame |
|---|---|---|
| Chronic success in ADVENT Trial treated subjects compared between treatment groups. | Occurrence of any of the following between the end of the Blanking Period (Day 90) in the ADVENT Trial through completion of follow-up in the ADVENT LTO study: Detectable AF, AFL+, or AT
Any Cardioversion for AF, AFL, or AT Re-ablation for AF, AFL, or AT | 90 day-3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Study eligibility criteria are defined below. Subjects who became deceased after completion of the ADVENT Trial will remain eligible for chart review data upon consent of a legally authorized representative (LAR). Subjects unable to complete the 7-day Holter monitor may consent to participate in the chart review portion only.
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Reddy | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grandview Medical Center | Birmingham | Alabama | 35243 | United States | ||
| Banner University Medical Center Phoenix |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41652117 | Derived | Reddy VY, Gerstenfeld EP, Mountantonakis SE, Patel C, Ellenbogen KA, Harding JD, Gibson DN, Natale A, Waks JW, Calkins H, Gupta SK, Woods CE, Whang W, Daccarett M, Cuoco FA, Delurgio DB, Richards E, Martens MD, Sutton B, Mansour M; ADVENT-LTO Study Investigators. Pulsed field ablation versus conventional thermal ablation for paroxysmal atrial fibrillation: 4-year outcomes in the ADVENT-LTO study. Nat Med. 2026 Apr;32(4):1444-1453. doi: 10.1038/s41591-026-04246-4. Epub 2026 Feb 6. |
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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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| Phoenix |
| Arizona |
| 85006 |
| United States |
| Mills Peninsula Health Services | Burlingame | California | 94010 | United States |
| Scripps Memorial Hospital | La Jolla | California | 92037 | United States |
| University of California, San Francisco | San Francisco | California | 94143-0628 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010-2975 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| St. Lukes Idaho Cardiology Associates | Boise | Idaho | 83702 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital (MGH) | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| St. Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Mount Sinai, Icahn School of Medicine | New York | New York | 10029 | United States |
| Northwell Health | New York | New York | 10075 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Doylestown Hospital | Doylestown | Pennsylvania | 18901 | United States |
| Presbyterian University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Pinnacle Health at Harrisburg Hospital | Wormleysburg | Pennsylvania | 17043 | United States |
| Trident Medical Center | Charleston | South Carolina | 29406 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| St. Thomas Research Institute, LLC | Nashville | Tennessee | 37205 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Texas Cardiac Arrhythmia Research | Austin | Texas | 78705 | United States |
| Virginia Commonwealth University Health System | Richmond | Virginia | 23219 | United States |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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