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.
Study Type
OBSERVATIONAL
Enrollment
312
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
Valley Heart Rhythm Specialists
Chandler, Arizona, United States
Ascension St. Vincent Hospital Indianapolis
Indianapolis, Indiana, United States
Corewell Health Research Institute
Royal Oak, Michigan, United States
Christ Hospital
Cincinnati, Ohio, United States
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 7-14 days
Physician reported outcome post procedure with active esophageal cooling.
Assessed using Physician Survey Questionnaire of multiple-choice questions.
Time frame: Up to 2 months
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Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States