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PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelectâ„¢ PFA System and followed through 36 months.
PulseSelect is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelectâ„¢ PFA System and followed through 36 months. Study visits will occur at 3, 6, 12, 24, and 36 months post-ablation, including required 24-hour Holter monitoring at 6, 12, 24, and 36 month visits. The PulseSelectâ„¢ PFA System used in this study is market approved and the ablation procedure will be performed according to hospital standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paroxysmal | Ablation using the PulseSelectâ„¢ PFA system |
| |
| Persistent | Ablation using the PulseSelectâ„¢ PFA system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PulseSelectâ„¢ PFA system | Device | Ablation using the PulseSelectâ„¢ PFA system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy-Freedom from Atrial Fibrillation | Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation using the PulseSelectâ„¢ PFA system. | 36-months after the index ablation procedure |
| Safety- Freedom from Device/Procedure Related Adverse Events | Estimate the rate of major procedural complications for catheter ablation using PulseSelectâ„¢ PFA system. | 6 months post-ablation] |
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Inclusion Criteria
Exclusion Criteria
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Subjects 18 years or older with a planned procedure using commercially available PulseSelectâ„¢ PFA System
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josman Suri | Contact | 7635050262 | josman.suri@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| Khaldoun Tarakji, MD | Medtronic CAS Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida Health (USF) | Recruiting | Tampa | Florida | 33606-3603 | United States |
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| Piedmont Heart Institute | Recruiting | Atlanta | Georgia | 30309 | United States |
|
| Endeavor Health Swedish Hospital | Recruiting | Chicago | Illinois | 60625 | United States |
|
| Pikeville Medical Center | Recruiting | Whitesburg | Kentucky | 41858-7428 | United States |
|
| Southcoast Health System | Recruiting | Fall River | Massachusetts | 02720 | United States |
|
| Beaumont Health System | Withdrawn | Royal Oak | Michigan | 48073 | United States |
| Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
|
| The Valley Hospital | Recruiting | New York | New York | 10025 | United States |
|
| Northwell Health Lenox Hill Hospital | Recruiting | New York | New York | 10075 | United States |
|
| Duke University Medical Center (DUMC) | Recruiting | Durham | North Carolina | 27710 | United States |
|
| Bethesda North Hospital | Recruiting | Cincinnati | Ohio | 45220 | United States |
|
| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 045218 | United States |
|
| Mount Carmel Grove City Medical Center | Recruiting | Grove City | Ohio | 43123 | United States |
|
| Doylestown Health Cardiology a division of Doylestown Health Physicians | Recruiting | Doylestown | Pennsylvania | 18901-2554 | United States |
|
| AnMed Health Center | Recruiting | Anderson | South Carolina | 29621 | United States |
|
| Medical University of South Carolina (MUSC) | Recruiting | Charleston | South Carolina | 29425-8908 | United States |
|
| Texas Health Research & Education Institute | Recruiting | Dallas | Texas | 75231-3815 | United States |
|
| University of Virginia Medical Center | Recruiting | Charlottesville | Virginia | 22908 | 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 |
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