Back to resultsRandomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation) (PULVAB)
Primary Purpose
Arrhythmias, Cardiac, Cardiovascular Diseases, Postoperative Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Conventional CABG
CABG+ PVI
CABG+ PVI+amiodarone
CABG+amiodarone
Sponsored by
About this trial
This is an interventional treatment trial for Arrhythmias, Cardiac focused on measuring Bipolar radiofrequency ablation, Atrial Fibrillation New Onset, CABG, Coronary artery disease, Postoperative atrial fibrillation
Eligibility Criteria
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
Sites / Locations
- Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.Recruiting
- A.V. Vishnevsky National Medical Research Center of Surgery.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Conventional CABG
CABG+ PVI
CABG+ PVI+amiodarone
CABG+amiodarone
Arm Description
Coronary artery bypass grafting (CABG) treatment (CABG group,n=70)
CABG + prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation (CABG +PVI group, n=70)
CABG+ prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation + amiodarone (CABG +PVI+ class III antiarrhythmic drug- amiodarone, group, n=70)
CABG+class III antiarrhythmic drug- amiodarone, group, n=70
Outcomes
Primary Outcome Measures
Incidence of atrial fibrillation after CABG
Major cardiovascular and cerebral events (MACCE), including death, nonfatal myocardial infarction, repeated revascularization using PCI or CABG, transitory ischemic attack (TIA) or stroke.
Secondary Outcome Measures
Sinus rhythm at the time of discharge of the patient from the hospital
Duration of mechanical ventilation
Incidence of implantation of the pacemaker
Volume of intraoperative bleeding
Time of CBP
Time clamping of the aorta
Length of stay in the intensive care unit
Duration of the hospitalization
Full Information
NCT ID
NCT03857711
First Posted
February 22, 2019
Last Updated
February 4, 2020
Sponsor
National Research Center of Surgery, Russia
Collaborators
Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.
1. Study Identification
Unique Protocol Identification Number
NCT03857711
Brief Title
Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)
Acronym
PULVAB
Official Title
Multicenter Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2016 (undefined)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Center of Surgery, Russia
Collaborators
Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac, Cardiovascular Diseases, Postoperative Atrial Fibrillation, Myocardial Ischemia
Keywords
Bipolar radiofrequency ablation, Atrial Fibrillation New Onset, CABG, Coronary artery disease, Postoperative atrial fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional CABG
Arm Type
Active Comparator
Arm Description
Coronary artery bypass grafting (CABG) treatment (CABG group,n=70)
Arm Title
CABG+ PVI
Arm Type
Active Comparator
Arm Description
CABG + prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation (CABG +PVI group, n=70)
Arm Title
CABG+ PVI+amiodarone
Arm Type
Active Comparator
Arm Description
CABG+ prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation + amiodarone (CABG +PVI+ class III antiarrhythmic drug- amiodarone, group, n=70)
Arm Title
CABG+amiodarone
Arm Type
Active Comparator
Arm Description
CABG+class III antiarrhythmic drug- amiodarone, group, n=70
Intervention Type
Procedure
Intervention Name(s)
Conventional CABG
Intervention Description
Coronary artery bypass grafting
Intervention Type
Procedure
Intervention Name(s)
CABG+ PVI
Intervention Description
CABG+ prophylactic epicardial bipolar radiofrequency isolation of the pulmonary veins
Intervention Type
Procedure
Intervention Name(s)
CABG+ PVI+amiodarone
Intervention Description
CABG+PVI+amiodarone (CABG+RFA + class III antiarrhythmic drug- amiodarone)
Intervention Type
Procedure
Intervention Name(s)
CABG+amiodarone
Primary Outcome Measure Information:
Title
Incidence of atrial fibrillation after CABG
Time Frame
Through study completion, an average of 1 year
Title
Major cardiovascular and cerebral events (MACCE), including death, nonfatal myocardial infarction, repeated revascularization using PCI or CABG, transitory ischemic attack (TIA) or stroke.
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Sinus rhythm at the time of discharge of the patient from the hospital
Time Frame
Through study completion, an average of 1 year
Title
Duration of mechanical ventilation
Time Frame
Through study completion, an average of 1 year
Title
Incidence of implantation of the pacemaker
Time Frame
Through study completion, an average of 1 year
Title
Volume of intraoperative bleeding
Time Frame
Through study completion, an average of 1 year
Title
Time of CBP
Time Frame
Through study completion, an average of 1 year
Title
Time clamping of the aorta
Time Frame
Through study completion, an average of 1 year
Title
Length of stay in the intensive care unit
Time Frame
Through study completion, an average of 1 year
Title
Duration of the hospitalization
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amiran Sh. Revishvili
Phone
+7 (499) 236-72-90
First Name & Middle Initial & Last Name or Official Title & Degree
Vadim A. Popov
Phone
+7 9166706609
Email
drpopov@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amiran Sh. Revishvili
Organizational Affiliation
A.V. Vishnevsky National Medical Research Center of Surgery. Moscow. Russian Federation.
Official's Role
Study Chair
Facility Information:
Facility Name
Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.
City
Kaliningrad
ZIP/Postal Code
236035
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuri A Schneider
First Name & Middle Initial & Last Name & Degree
Yuri A Schneider
Facility Name
A.V. Vishnevsky National Medical Research Center of Surgery.
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amiran Sh. Revishvili
Phone
+7 (499) 236-72-90
First Name & Middle Initial & Last Name & Degree
Vadim A. Popov
12. IPD Sharing Statement
Learn more about this trial
Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)
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