Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)
NCT ID: NCT03857711
Last Updated: 2020-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
280 participants
INTERVENTIONAL
2016-09-01
2022-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional CABG
Coronary artery bypass grafting (CABG) treatment (CABG group,n=70)
Conventional CABG
Coronary artery bypass grafting
CABG+ PVI
CABG + prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation (CABG +PVI group, n=70)
CABG+ PVI
CABG+ prophylactic epicardial bipolar radiofrequency isolation of the pulmonary veins
CABG+ PVI+amiodarone
CABG+ prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation + amiodarone (CABG +PVI+ class III antiarrhythmic drug- amiodarone, group, n=70)
CABG+ PVI+amiodarone
CABG+PVI+amiodarone (CABG+RFA + class III antiarrhythmic drug- amiodarone)
CABG+amiodarone
CABG+class III antiarrhythmic drug- amiodarone, group, n=70
CABG+amiodarone
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* patients had indications for two or more coronary arteries to be bypassed
* no history of AF
Exclusion Criteria
* 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
45 Years
80 Years
ALL
No
Sponsors
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Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.
UNKNOWN
National Research Center of Surgery, Russia
OTHER_GOV
Responsible Party
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Stepanova Yulia Aleksandrovna
Clinical Professor
Principal Investigators
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Amiran Sh. Revishvili
Role: STUDY_CHAIR
A.V. Vishnevsky National Medical Research Center of Surgery. Moscow. Russian Federation.
Locations
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Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.
Kaliningrad, , Russia
A.V. Vishnevsky National Medical Research Center of Surgery.
Moscow, , Russia
Countries
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Central Contacts
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Amiran Sh. Revishvili
Role: CONTACT
Facility Contacts
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Yuri A Schneider
Role: primary
Amiran Sh. Revishvili
Role: primary
Other Identifiers
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q9ics7t8
Identifier Type: -
Identifier Source: org_study_id
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