Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)

Not Applicable

• Conditions: Postoperative Atrial Fibrillation; Myocardial Ischemia; Arrhythmias, Cardiac; Cardiovascular Diseases
• Interventions: Procedure: CABG+ PVI; Procedure: Conventional CABG; Procedure: CABG+amiodarone; Procedure: CABG+ PVI+amiodarone

• Registration Number: NCT03857711
• Lead Sponsor: National Research Center of Surgery, Russia

Brief 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.

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2016-12-01
• Status Verified: 2019-02
• Study First Submitted: 2019-02-22
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-02-28
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-06
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• patients must have signed an informed consent.
• patients had indications for two or more coronary arteries to be bypassed
• no history of AF

Exclusion Criteria

• acute coronary syndrome
• previous CABG.
• a significant decrease in the contractile function of the heart (EF <40%)
• significant heart valve disease requiring surgical repair
• long-standing persistent, persistent, or paroxysmal forms of atrial fibrillation
• respiratory failure
• left ventricular aneurysm requiring surgical correction
• chronic renal failure (≤60 mL/min/1⋅73 m2)
• chronic diseases that make a significant contribution to the prognosis of life (e.g. oncology)
• participation in other clinical trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CABG+ PVI	CABG+ PVI	CABG + prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation (CABG +PVI group, n=70)
Conventional CABG	Conventional CABG	Coronary artery bypass grafting (CABG) treatment (CABG group,n=70)
CABG+amiodarone	CABG+amiodarone	CABG+class III antiarrhythmic drug- amiodarone, group, n=70
CABG+ PVI+amiodarone	CABG+ PVI+amiodarone	CABG+ prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation + amiodarone (CABG +PVI+ class III antiarrhythmic drug- amiodarone, group, n=70)

Primary Outcome Measures

Name	Time	Method
Incidence of atrial fibrillation after CABG	Through study completion, an average of 1 year
Major cardiovascular and cerebral events (MACCE), including death, nonfatal myocardial infarction, repeated revascularization using PCI or CABG, transitory ischemic attack (TIA) or stroke.	Through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
Time of CBP	Through study completion, an average of 1 year
Duration of the hospitalization	Through study completion, an average of 1 year
Time clamping of the aorta	Through study completion, an average of 1 year
Sinus rhythm at the time of discharge of the patient from the hospital	Through study completion, an average of 1 year
Duration of mechanical ventilation	Through study completion, an average of 1 year
Incidence of implantation of the pacemaker	Through study completion, an average of 1 year
Volume of intraoperative bleeding	Through study completion, an average of 1 year
Length of stay in the intensive care unit	Through study completion, an average of 1 year

Trial Locations

Locations (2)

Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.; 🇷🇺 Kaliningrad, Russian Federation

A.V. Vishnevsky National Medical Research Center of Surgery.; 🇷🇺 Moscow, Russian Federation