Clinical trial NCT03857711: Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)
Official title: Multicenter Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arrhythmias, Cardiac
Cardiovascular Diseases
Postoperative Atrial Fibrillation
Myocardial Ischemia
Keywords: Bipolar radiofrequency ablation
Atrial Fibrillation New Onset
CABG
Coronary artery disease
Postoperative atrial fibrillation
Lead sponsor: National Research Center of Surgery, Russia
Sponsor class: OTHER_GOV
Collaborators: name: Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.
First posted: 2019-02-28
Enrollment: 280
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of atrial fibrillation after CABG
timeFrame: Through study completion, an average of 1 year
measure: Major cardiovascular and cerebral events (MACCE), including death, nonfatal myocardial infarction, repeated revascularization using PCI or CABG, transitory ischemic attack (TIA) or stroke.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Sinus rhythm at the time of discharge of the patient from the hospital
timeFrame: Through study completion, an average of 1 year
measure: Duration of mechanical ventilation
timeFrame: Through study completion, an average of 1 year
measure: Incidence of implantation of the pacemaker
timeFrame: Through study completion, an average of 1 year
measure: Volume of intraoperative bleeding
timeFrame: Through study completion, an average of 1 year
measure: Time of CBP
timeFrame: Through study completion, an average of 1 year
measure: Time clamping of the aorta
timeFrame: Through study completion, an average of 1 year
measure: Length of stay in the intensive care unit
timeFrame: Through study completion, an average of 1 year
measure: Duration of the hospitalization
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kaliningrad
country: Russian Federation
facility: Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.
city: Moscow
country: Russian Federation
facility: A.V. Vishnevsky National Medical Research Center of Surgery.
Study officials:
affiliation: A.V. Vishnevsky National Medical Research Center of Surgery. Moscow. Russian Federation.
name: Amiran Sh. Revishvili
role: STUDY_CHAIR
References: