Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)

Study Overview
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Brief Summary
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To compare prophylactic strategies of atrial fibrillation in patients with CAD and without AF.

Detailed Description
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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.

Official Title
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Multicenter Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)

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

Intervention / Treatment
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* Procedure: Conventional CABG
* Procedure: CABG+ PVI
* Procedure: CABG+ PVI+amiodarone
* Procedure: CABG+amiodarone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional CABG<br>Coronary artery bypass grafting (CABG) treatment (CABG group,n=70) | Procedure: Conventional CABG<br>* Coronary artery bypass grafting<br>|
| Active Comparator: CABG+ PVI<br>CABG + prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation (CABG +PVI group, n=70) | Procedure: CABG+ PVI<br>* CABG+ prophylactic epicardial bipolar radiofrequency isolation of the pulmonary veins<br>|
| Active Comparator: CABG+ PVI+amiodarone<br>CABG+ prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation + amiodarone (CABG +PVI+ class III antiarrhythmic drug- amiodarone, group, n=70) | Procedure: CABG+ PVI+amiodarone<br>* CABG+PVI+amiodarone (CABG+RFA + class III antiarrhythmic drug- amiodarone)<br>|
| Active Comparator: CABG+amiodarone<br>CABG+class III antiarrhythmic drug- amiodarone, group, n=70 | Procedure: CABG+amiodarone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Time of CBP |  | Through study completion, an average of 1 year | 
| Time clamping of the aorta |  | Through study completion, an average of 1 year | 
| Length of stay in the intensive care unit |  | Through study completion, an average of 1 year | 
| Duration of the hospitalization |  | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar radiofrequency ablation, Atrial Fibrillation New Onset, CABG, Coronary artery disease, Postoperative atrial fibrillation