Status:
UNKNOWN
Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)
Lead Sponsor:
National Research Center of Surgery, Russia
Collaborating Sponsors:
Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.
Conditions:
Arrhythmias, Cardiac
Cardiovascular Diseases
Eligibility:
All Genders
45-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- patients must have signed an informed consent.
- patients had indications for two or more coronary arteries to be bypassed
- no history of AF
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT03857711
Start Date
September 1 2016
End Date
December 1 2022
Last Update
February 6 2020
Active Locations (2)
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1
Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.
Kaliningrad, Russia, 236035
2
A.V. Vishnevsky National Medical Research Center of Surgery.
Moscow, Russia, 117997