Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)

Cardiovascular Diseases Clinical Trial

— PULVAB  

Official title:

Multicenter Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03857711
• Other study ID #: q9ics7t8
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2019
• Source: National Research Center of Surgery, Russia
• Contact: Amiran Sh. Revishvili
• Phone: +7 (499) 236-72-90
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Conventional CABG
Coronary artery bypass grafting
• CABG+ PVI
CABG+ prophylactic epicardial bipolar radiofrequency isolation of the pulmonary veins
• CABG+ PVI+amiodarone
CABG+PVI+amiodarone (CABG+RFA + class III antiarrhythmic drug- amiodarone)
• CABG+amiodarone

Locations

Country	Name	City	State
Russian Federation	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

Sponsors (2)

Lead Sponsor	Collaborator
National Research Center of Surgery, Russia	Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of atrial fibrillation after CABG		Through study completion, an average of 1 year
Primary	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	Sinus rhythm at the time of discharge of the patient from the hospital		Through study completion, an average of 1 year
Secondary	Duration of mechanical ventilation		Through study completion, an average of 1 year
Secondary	Incidence of implantation of the pacemaker		Through study completion, an average of 1 year
Secondary	Volume of intraoperative bleeding		Through study completion, an average of 1 year
Secondary	Time of CBP		Through study completion, an average of 1 year
Secondary	Time clamping of the aorta		Through study completion, an average of 1 year
Secondary	Length of stay in the intensive care unit		Through study completion, an average of 1 year
Secondary	Duration of the hospitalization		Through study completion, an average of 1 year