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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
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 19, 2014
Last Updated
November 12, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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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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