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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
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Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be screened for enrollment, prospectively or retrospectively, to this sub-study per inclusion and exclusion criteria.
Enrolled QDOT PAS subjects are defined as consented patients with symptomatic paroxysmal atrial fibrillation (PAF) enrolled in the REAL AF registry. These enrolled subjects will be treated with the commercially available QDOT MICROâ„¢ system (QDOT MICROâ„¢ catheter and nGENâ„¢ generator) in conjunction with VISITAG SURPOINTâ„¢ Module. Subjects are required to complete scheduled assessments within 12 months of the index procedure, and additional two assessments at 24 and 36-months post procedure. Retrospective consecutive patients from the REAL AF registry, who were ablated with the QDOT MICROâ„¢ system, may be enrolled into the sub-study if the patient meets eligibility criteria and provides consent for additional follow-up of 24 and 36-months
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation Procedure | Device | Ablation Procedure for paroxysmal atrial fibrillation |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module | Adverse events from post-procedure through 7-day post ablation visit. | Day 0-7 post ablation |
| Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 12-months. | Freedom from atrial arrhythmia recurrence at 12 months post procedure. | 12 months |
| Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 24-months. | Freedom from atrial arrhythmia recurrence at 24 months post procedure. | 24 months |
| Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months. | Freedom from atrial arrhythmia recurrence at 36 months post procedure. | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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Study population will consist of patients in the REAL AF registry who have symptomatic PAF and will have, or have undergone, ablation procedures using the QDOT MICROâ„¢ System with VISITAG SURPOINTâ„¢ Module
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Moss | Contact | 615-448-5770 | jmoss@hrcrs.com |
| Name | Affiliation | Role |
|---|---|---|
| Brian Sanchez, MD | J & J Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrhythmia Institute at Grandview | Recruiting | Birmingham | Alabama | 35209 | United States |
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| Mobile Cardiology Associates | Recruiting | Mobile | Alabama | 36608 | United States |
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| Community Memorial Health System | Recruiting | Ventura | California | 93003 | United States |
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| Medical City - HCA | Recruiting | Aurora | Colorado | 80012 | United States |
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| Naples Community Hospital | Withdrawn | Naples | Florida | 34102 | United States |
| Sarasota Memorial Health | Recruiting | Sarasota | Florida | 34239 | United States |
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| Piedmont Healthcare | Recruiting | Atlanta | Georgia | 30309 | United States |
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| Norton Heart and Vascular Institute | Recruiting | Louisville | Kentucky | 40205 | United States |
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| The Brigham and Womens Hospital | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
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| Sparrow Clinical Research Institute | Recruiting | Lansing | Michigan | 48912 | United States |
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| Trinity Health-Michigan Heart | Recruiting | Ypsilanti | Michigan | 48197 | United States |
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| The Christ Hospital | Recruiting | Cincinnati | Ohio | 45219 | United States |
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| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45221 | United States |
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| University of Pennsylvania (UPENN) | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Allegheny Health | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
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| Centra Health, Inc.dba Stroobants Cardiovascular Center | Recruiting | Lynchburg | Virginia | 24501 | United States |
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| Bon Secours Medical Group - Richmond Specialty Care | Recruiting | Richmond | Virginia | 23226 | United States |
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| Valley Health System | Recruiting | Winchester | Virginia | 22601 | United States |
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| Multicare Health Systems-Pulse Heart | Recruiting | Puyallup | Washington | 98372 | United States |
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| Franciscan Heart and Vascular Associates | Recruiting | Tacoma | Washington | 98401 | United States |
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| Mercy Health | Recruiting | Janesville | Wisconsin | 53548 | United States |
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| 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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