Cardiovascular Diseases Clinical Trial
— PULVABOfficial title:
Multicenter Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)
To compare prophylactic strategies of atrial fibrillation in patients with CAD and without AF.
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/1ยท73 m2) - chronic diseases that make a significant contribution to the prognosis of life (e.g. oncology) - participation in other clinical trials |
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 |
Lead Sponsor | Collaborator |
---|---|
National Research Center of Surgery, Russia | Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia. |
Russian Federation,
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 |
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