Atrial Fibrillation Clinical Trial
Official title:
Ablation of the Epicardial Fat Pads to Treat Paroxysmal Atrial Fibrillation During Coronary Artery Bypass Grafting
The aim of this prospective randomized study was to assess the efficacy of ablation of the ganglionated plexi localized in the epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.
Status | Recruiting |
Enrollment | 264 |
Est. completion date | February 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - History of paroxysmal atrial fibrillation (recurrent episodes for at least 1 years, with 2 documented episodes over the last 6 months) - Indication for cardiac surgery (e.g. coronary artery bypass grafting, valve repair/replacement) according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for cardiac surgery Exclusion Criteria: Previous heart surgery or atrial fibrillation ablation procedure Emergency coronary artery bypass grafting Unstable angina or heart failure Persistent atrial fibrillation Planned maze procedure or pulmonary vein isolation Unwillingness to participate |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Russian Federation | State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation | Novosibirsk | |
Russian Federation | Cardiology Research Institute | Tomsk |
Lead Sponsor | Collaborator |
---|---|
Meshalkin Research Institute of Pathology of Circulation |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug | 12 month | Yes | |
Secondary | atrial fibrillation burden | 12 month | Yes | |
Secondary | incidence of congestive heart failure | 12 month | Yes | |
Secondary | incidence of sustained ventricular arrhythmias | 12 month | Yes | |
Secondary | rehospitalization | 12 month | Yes | |
Secondary | stroke or transient ischemic attack | 12 month | Yes | |
Secondary | number of Deaths | 12 month | Yes |
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