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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
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To generate real-world evidence from the parent study, REAL AF registry, on the use of Thermocool SmartTouch SF (STSF) catheter in ablation for the treatment of paroxysmal atrial fibrillation (PAF).
The primary objective of this registry is to evaluate effectiveness and safety of Thermocool STSF catheter to support an indication extension of the STSF catheter using real world data from the REAL AF registry. Subjects included in the registry will be those in which the STSF catheter is used for the treatment of symptomatic PAF in antiarrhythmic drug (AAD) naive patients as an initial rhythm control therapy. The registry will involve retrospective analysis of data prospectively collected from the REAL AF registry. The registry will include consecutive, eligible patients from the REAL AF registry, starting from October 2021 who meet the sub-study eligibility criteria until 344 eligible subjects are identified. Eligible patients from all participating centers in the REAL AF registry will be included, except for sites with standard-of-care rhythm monitoring less than 48 hours and those that do not perform 6-12 month follow up as standard of care.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation | Device | Ablation procedure using the Thermocool Smarttouch SF |
| Measure | Description | Time Frame |
|---|---|---|
| Primary effectiveness | Freedom from atrial arrhythmia recurrence | 12-months |
| Primary effectiveness | Any repeat ablation procedure, use of class I/III AAD, or cardioversion post-blanking for treatment of atrial arrhythmia will be deemed failure of primary effectiveness endpoint. | Post 3-month blanking period |
| Primary safety | A composite of procedure or device related adverse events post index ablation. | 7 days |
| Primary safety | Atrio-esophageal fistula, severe pulmonary vein stenosis and device or procedure related death post index ablation | 90 days |
| Primary safety | Cardiac tamponade/pericardial effusion post index ablation | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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The sub-study population will consist of Class I/III AAD naïve PAF patients who underwent ablation procedure using the THERMOCOOL STSF Catheter as their first rhythm control therapy. The study will include consecutive, eligible patients from the REAL AF registry, starting from October 2021, who meet the sub-study eligibility criteria until 344 eligible subjects are identified.
Eligible patients from all participating centers in the REAL AF registry will be included, except for sites with standard-of-care rhythm monitoring less than 48 hours, and those that do not perform 6-12 months follow-up as standard-of-care.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrhythmia Institute at Grandview | Birmingham | Alabama | 35243 | United States | ||
| Community Memorial Hospital |
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| Ventura |
| California |
| 93303 |
| United States |
| Ascension St. Vincent's | Jacksonville | Florida | 32204 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| Northshore University Health System | Evanston | Illinois | 60201 | United States |
| Ascension St. Vincent's Hospital | Indianapolis | Indiana | 46260 | United States |
| Michigan Heart | Ypsilanti | Michigan | 48197 | United States |
| Mount Carmel Columbus Cardiology Consultants | Columbus | Ohio | 43213 | United States |
| University of Pennsylvania, Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15222 | United States |
| Upstate Cardiology | Greenville | South Carolina | 29607 | United States |
| Centra Health, Inc. (dba Stroobants Cardiovascular Center) | Lynchburg | Virginia | 24501 | 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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