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SPHERE Per-AF Post-Approval Study is a prospective, multi-center, non-randomized, observational trial. Subjects will be treated with the Sphere-9â„¢ Catheter and Afferaâ„¢ Ablation System and followed through 36 months.
The purpose of the study is to evaluate the long-term effectiveness and safety of the Sphere-9â„¢ Catheter and Afferaâ„¢ Ablation System in a post-approval setting for the treatment of drug refractory, recurrent, symptomatic, persistent AF (episode duration less than one year).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persistent Atrial Fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sphere-9â„¢ Catheter and Afferaâ„¢ Ablation System | Device | De novo pulmonary vein isolation procedure using commercially available Sphere-9â„¢ Catheter and Afferaâ„¢ Ablation System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Objective | Estimate the primary safety adverse event (AE) rate for ablation using the Sphere-9â„¢ Catheter and Afferaâ„¢ Ablation System. | Through 180 days Post-Procedure |
| Primary Effectiveness Objective | Estimate the 36-month freedom from atrial fibrillation (AF), atrial tachycardia (AT) or atrial flutter (AFL) recurrence following ablation procedure using the Sphere-9â„¢ Catheter and Afferaâ„¢ Ablation System. | Through 36 months Post-Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects 18 years or older with a planned de novo procedure using commercially available Sphere-9â„¢ Catheter and Afferaâ„¢ Ablation System.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Hospital | Birmingham | Alabama | 35294 | United States | ||
| Sarasota Memorial Hospital |
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| Sarasota |
| Florida |
| 34239 |
| United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Montefiore Medical Center | New York | New York | 10467 | United States |
| Atrium Health Carolinas Medical Center | Charlotte | North Carolina | 28230 | United States |
| OhioHealth | Columbus | Ohio | 43214 | United States |
| Doylestown Health Cardiology | Doylestown | Pennsylvania | 18901 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Texas Health Resources | Fort Worth | Texas | 76104 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22903 | United States |
| Centra Medical Group 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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