Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)

National Research Center of Surgery, Russia

Status: Unknown

Conditions: Postoperative Atrial Fibrillation; Myocardial Ischemia; Arrhythmias, Cardiac; Cardiovascular Diseases

Treatments: Procedure: CABG+ PVI+amiodarone; Procedure: Conventional CABG; Procedure: CABG+amiodarone; Procedure: CABG+ PVI

Study type: Interventional

Funder types: Other

Identifiers

NCT03857711

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Details and patient eligibility

About

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

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 4 patient groups

Conventional CABG

Active Comparator group

Description:

Coronary artery bypass grafting (CABG) treatment (CABG group,n=70)

Treatment:

Procedure: Conventional CABG

CABG+ PVI

Active Comparator group

Description:

CABG + prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation (CABG +PVI group, n=70)

Treatment:

Procedure: CABG+ PVI

CABG+ PVI+amiodarone

Active Comparator group

Description:

CABG+ prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation + amiodarone (CABG +PVI+ class III antiarrhythmic drug- amiodarone, group, n=70)

Treatment:

Procedure: CABG+ PVI+amiodarone

CABG+amiodarone

Active Comparator group

Description:

CABG+class III antiarrhythmic drug- amiodarone, group, n=70

Treatment:

Procedure: CABG+amiodarone