Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 210
Summary
- Conditions
- Arrhythmias Cardiac
- Cardiovascular Diseases
- Myocardial Ischemia
- Postoperative Atrial Fibrillation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 45 years and 80 years
- Gender
- Both males and females
Description
Prospective, multicenter, randomized trial, intended to compare three prophylactic strategies of atrial fibrillation in patients with coronary artery disease and without history of atrial fibrillation. The study includes 4 groups of patients: Group I (conventional CABG) Group II (CABG + pulmonary ve...
Prospective, multicenter, randomized trial, intended to compare three prophylactic strategies of atrial fibrillation in patients with coronary artery disease and without history of atrial fibrillation. The study includes 4 groups of patients: Group I (conventional CABG) Group II (CABG + pulmonary veins isolation). Concomitant CABG and epicardial bipolar radiofrequency pulmonary veins isolation. Group III (CABG+ pulmonary veins isolation + amiodarone). Concomitant CABG and epicardial bipolar radiofrequency pulmonary veins ablation with administration of amiodarone in postoperative periode. Group IV (CABG+ amiodarone). Conventional CABG with administration of amiodarone in postoperative periode.
Tracking Information
- NCT #
- NCT03857711
- Collaborators
- Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.
- Investigators
- Study Chair: Amiran Sh. Revishvili A.V. Vishnevsky National Medical Research Center of Surgery. Moscow. Russian Federation.
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