Surgical Ablation of Long-standing Persistent AF During CABG (LABARFA)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Biatrial radiofrequency ablation and CABG
Left atrial radiofrequency ablation and CABG
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring ablation, CABG, Long-standing persistent Atrial Fibrillation
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) long-term persistent AF 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
Biatrial radiofrequency ablation and CABG
Left atrial radiofrequency ablation and CABG
Arm Description
Biatrial radiofrequency ablation during CABG
Left atrial radiofrequency ablation during CABG
Outcomes
Primary Outcome Measures
Freedom from atrial fibrillation
Freedom from AF. All cases of AF after surgical intervention.
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
Cardiovascular events
All cases of stroke, cardiac infarction, thromboembolism, bleeding and death
Full Information
NCT ID
NCT02246790
First Posted
September 19, 2014
Last Updated
November 12, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT02246790
Brief Title
Surgical Ablation of Long-standing Persistent AF During CABG
Acronym
LABARFA
Official Title
Surgical Ablation of Long-standing Persistent Atrial Fibrillation During CABG Through Continuous Subcutaneous Monitoring
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 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
Purpose. Comparison of outcomes in patients underwent CABG combined with left atrial and biatrial radiofrequency ablation of long-standing persistent atrial fibrillation.
Hypothesis of the study - patients with long-standing persistent atrial fibrillation and coronary artery disease after CABG in combination with biatrial RFA have a better outcomes for the freedom of AF compared with patients undergoing left atrial RFA during CABG.
Detailed Description
This is a single blinded prospective randomized study involving 116 patients with long-standing persistent AF and coronary artery disease. 116 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome (freedom fro AF) measure by 12% in the biatrial group over left atrial group. Patients are divided into two groups, group I - biatrial + CABG (58 patients), and group II - left atrial + CABG (58 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 kind of surgical ablation. 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
Coronary Artery Disease
Keywords
ablation, CABG, Long-standing persistent Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biatrial radiofrequency ablation and CABG
Arm Type
Active Comparator
Arm Description
Biatrial radiofrequency ablation during CABG
Arm Title
Left atrial radiofrequency ablation and CABG
Arm Type
Active Comparator
Arm Description
Left atrial radiofrequency ablation during CABG
Intervention Type
Procedure
Intervention Name(s)
Biatrial radiofrequency ablation and CABG
Intervention Description
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant biatrial RFA during CPB.
Intervention Type
Procedure
Intervention Name(s)
Left atrial radiofrequency ablation and CABG
Intervention Description
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant left atrial RFA during CPB.
Primary Outcome Measure Information:
Title
Freedom from atrial fibrillation
Description
Freedom from AF. All cases of AF after surgical intervention.
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
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
75 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) long-term persistent AF 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
Sardor Rakhmonov
Phone
+79231278557
Email
sardor5507@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
Sardor Rakhmonov
Phone
+79231278557
Email
sardor5507@mail.ru
12. IPD Sharing Statement
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Surgical Ablation of Long-standing Persistent AF During CABG
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