The Assessment of Progression of Paroxysmal AF After CABG
Primary Purpose
Paroxysmal Atrial Fibrillation, Coronary Artery Disease
Status
Unknown status
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
CABG+Pulmonary vein isolation procedure
Isolated CABG
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation, Coronary Artery Disease focused on measuring paroxysmal atrial fibrillation, CABG, pulmonary vein isolation
Eligibility Criteria
Inclusion Criteria:
- American College of Cardiology (ACC)/ American Heart Association (AHA) -Indications for CABG
- At least 2 ECG-verified (12-channel ECG, Holter telemetry) symptomatic paroxysmal atrial fibrillation episodes within last 12 months
- The patient's consent to participate in the study
Exclusion Criteria:
- Intolerance of antiarrhythmic drugs
- Heart valve disease requiring invasive treatment
- Left atria more than 6.5 cm
- Prior cardiac surgery
- Active pacemaker treatment
- Active anti-arrhythmic treatment (AAD) class I and III
- Contraindication to oral anticoagulant/heparin treatment
- Ejection fraction less than 30 % (EF < 30 %) assessed by transthoracic echocardiography
Sites / Locations
- Meshalkin State Research Institute of Circulation PathologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CABG+pulmonary vein isolation
Isolated CABG
Arm Description
CABG+pulmonary vein isolation procedure
Isolated CABG procedure
Outcomes
Primary Outcome Measures
Progression of atrial fibrillation
Combined indicator consist of recurrence of AF, increased frequency of AF, progression to persistent AF.
Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds. Patients with AF>0.5% were classified as non-responders.
Secondary Outcome Measures
Hospitalization due to atrial fibrillation after surgery
All cases of hospitalization due to atrial fibrillation after surgery
Cardiovascular events
All cases of stroke, cardiac infarction, thromboembolism, bleeding and death
Full Information
NCT ID
NCT02246803
First Posted
September 19, 2014
Last Updated
September 21, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT02246803
Brief Title
The Assessment of Progression of Paroxysmal AF After CABG
Official Title
The Assessment of Progression of Paroxysmal Atrial Fibrillation in Patients After Coronary Artery Bypass Grafting Through Continuous Subcutaneous Monitoring
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is a comparative evaluation of progression of paroxysmal atrial fibrillation in patients with coronary artery disease after isolated CABG and CABG combined with pulmonary vein isolation.
Hypothesis of the study - patients with paroxysmal atrial fibrillation and coronary artery disease after CABG in combination with isolation of the pulmonary veins have a better outcomes for the progression of AF compared with patients undergoing isolated CABG.
Detailed Description
This is a single blinded prospective randomized study involving 72 patients with paroxysmal AF and coronary artery disease. 72 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure by 10% in the CABG + pulmonary veins isolation group over isolated CABG group. Patients are divided into two groups, group I - isolated CABG (36 patients), and group II - CABG and pulmonary veins isolation (36 patients). Randomization is conducted by using accidental sampling before operation. The blinding process is applied to a patient, who is informed about received coronary artery bypass grafting, but don't know about pulmonary vein isolation. Subcutaneous cardiac monitor is implanted to all patients for cardiac rhythm monitoring.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Coronary Artery Disease
Keywords
paroxysmal atrial fibrillation, CABG, pulmonary vein isolation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CABG+pulmonary vein isolation
Arm Type
Active Comparator
Arm Description
CABG+pulmonary vein isolation procedure
Arm Title
Isolated CABG
Arm Type
Active Comparator
Arm Description
Isolated CABG procedure
Intervention Type
Procedure
Intervention Name(s)
CABG+Pulmonary vein isolation procedure
Intervention Description
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation in CBP prior to occlusion and CABG
Intervention Type
Procedure
Intervention Name(s)
Isolated CABG
Intervention Description
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion.
Primary Outcome Measure Information:
Title
Progression of atrial fibrillation
Description
Combined indicator consist of recurrence of AF, increased frequency of AF, progression to persistent AF.
Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds. Patients with AF>0.5% were classified as non-responders.
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
Hospitalization due to atrial fibrillation after surgery
Description
All cases of hospitalization due to atrial fibrillation after surgery
Time Frame
Within three years after surgery
Title
Cardiovascular events
Description
All cases of stroke, cardiac infarction, thromboembolism, bleeding and death
Time Frame
Within three years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American College of Cardiology (ACC)/ American Heart Association (AHA) -Indications for CABG
At least 2 ECG-verified (12-channel ECG, Holter telemetry) symptomatic paroxysmal atrial fibrillation episodes within last 12 months
The patient's consent to participate in the study
Exclusion Criteria:
Intolerance of antiarrhythmic drugs
Heart valve disease requiring invasive treatment
Left atria more than 6.5 cm
Prior cardiac surgery
Active pacemaker treatment
Active anti-arrhythmic treatment (AAD) class I and III
Contraindication to oral anticoagulant/heparin treatment
Ejection fraction less than 30 % (EF < 30 %) assessed by transthoracic echocardiography
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Kareva
Phone
+79069952839
Email
julia11108@mail.ru
Facility Information:
Facility Name
Meshalkin State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Kareva, PhD
Phone
+79069952839
Email
julia11108@mail.ru
12. IPD Sharing Statement
Learn more about this trial
The Assessment of Progression of Paroxysmal AF After CABG
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