NCT03857711

Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)

Multicenter Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: National Research Center of Surgery, Russia · Other Government
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To compare prophylactic strategies of atrial fibrillation in patients with CAD and without AF.

Detailed 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 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.

Conditions

• Arrhythmias, Cardiac
• Cardiovascular Diseases
• Postoperative Atrial Fibrillation
• Myocardial Ischemia

Interventions

Type	Name	Description
PROCEDURE	Conventional CABG	Coronary artery bypass grafting
PROCEDURE	CABG+ PVI	CABG+ prophylactic epicardial bipolar radiofrequency isolation of the pulmonary veins
PROCEDURE	CABG+ PVI+amiodarone	CABG+PVI+amiodarone (CABG+RFA + class III antiarrhythmic drug- amiodarone)
PROCEDURE	CABG+amiodarone

Timeline

• Start date: 2016-09-01
• Primary completion: 2016-12-01
• Completion: 2022-12-01
• First posted: 2019-02-28
• Last updated: 2020-02-06

Locations

2 sites across 1 country: Russia