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| Name | Class |
|---|---|
| Attune Medical | OTHER |
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This is a multi-center sub-study examining the effectiveness of active esophageal cooling on subjects undergoing left atrial ablation for symptomatic Paroxysmal Atrial Fibrillation or Persistent Atrial Fibrillation.
Treatment of atrial fibrillation, using pulmonary vein isolation, involves some risks to collateral structure, including the esophagus. Active esophageal cooling has shown benefits in multiple studies when used in the treatment of Paroxysmal Atrial Fibrillation or Persistent Atrial Fibrillation during left atrial ablation. The largest randomized, controlled trial to date, the IMPACT study, found an 83% reduction in endoscopically identified esophageal lesions when using the active cooling, with a dedicated device, compared to standard esophageal monitoring, with no difference in Atrial Fibrillation recurrence rates at follow-up. Recent analyses have suggested additional effects from active esophageal cooling during pulmonary vein isolation, including reductions in procedure time, reductions in fluoroscopy usage, reductions in post-ablation discomfort, and improvements in long-term freedom from arrhythmia. Further investigation of these associations is important to better understand the magnitude of these findings in a variety of clinical settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects who undergo left atrial ablation using esophogeal cooling | Study population will consist of consecutive male and female patients in the REAL AF Registry who have symptomatic Paroxysmal Atrial Fibrillation (PAF) or Persistent Atrial Fibrillation (PsAF) and undergo left atrial ablation with active esophageal cooling for the treatment of atrial fibrillation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atrial Ablation | Device | Left atrial radiofrequency ablation for the treatment of atrial fibrillation; this may include Pulmonary Vein Isolation (PVI) with or without additional ablation lesions as warranted during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| To measure procedural efficacy after atrial fibrillation ablation in patients treated with active esophageal cooling. | Freedom from atrial arrhythmia recurrence at 90 days post procedure. | 90 days |
| To measure procedural efficacy after atrial fibrillation ablation in patients treated with active esophageal cooling. | Freedom from atrial arrhythmia recurrence at 12 months post procedure | 12 months |
| To measure long term safety after atrial fibrillation in patients treated with active esophageal cooling. | Adverse events from post-procedure through the 12-month office visit date | up to 12-months |
| Patient reported outcomes in patients treated with active esophageal cooling. | Outcomes reported in modified Gastroesophageal Reflux Disease (GERD) questionnaire. Scale will be scored from "0" (no symptoms) to "3" (maximum symptoms). Higher scores indicate a worse outcome. | 7-14 days |
| Physician reported outcome post procedure with active esophageal cooling. | Assessed using Physician Survey Questionnaire of multiple-choice questions. | Up to 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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The sub-study will consist of consecutive male and female patients enrolled in the REAL AF Registry who have symptomatic Paroxysmal Atrial Fibrillation (PAF) or Persistent Atrial Fibrillation (PsAF) and undergo left atrial ablation for the treatment of atrial fibrillation.
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany Sharkoski, MPH | Haemonetics Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Heart Rhythm Specialists | Chandler | Arizona | 85224 | United States | ||
| Ascension St. Vincent Hospital Indianapolis |
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| Indianapolis |
| Indiana |
| 46260 |
| United States |
| Corewell Health Research Institute | Royal Oak | Michigan | 48067 | United States |
| Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| MultiCare Institute for Research & Innovation | Tacoma | Washington | 98001 | 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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