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Surgical Ablation of Long-standing Persistent AF During CABG (LABARFA)

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ClinicalTrials.gov Identifier: NCT02246790
Recruitment Status : Unknown
Verified November 2015 by Alexander Romanov, Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
First Posted : September 23, 2014
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
Alexander Romanov, Meshalkin Research Institute of Pathology of Circulation

Tracking Information
First Submitted Date  ICMJE September 19, 2014
First Posted Date  ICMJE September 23, 2014
Last Update Posted Date November 13, 2015
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2014)
Freedom from atrial fibrillation [ Time Frame: up to 36 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02246790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2014)
Cardiovascular events [ Time Frame: Within three years after surgery ]
All cases of stroke, cardiac infarction, thromboembolism, bleeding and death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgical Ablation of Long-standing Persistent AF During CABG
Official Title  ICMJE Surgical Ablation of Long-standing Persistent Atrial Fibrillation During CABG Through Continuous Subcutaneous Monitoring
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Procedure: Biatrial radiofrequency ablation and CABG
    Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant biatrial RFA during CPB.
  • Procedure: Left atrial radiofrequency ablation and CABG
    Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant left atrial RFA during CPB.
Study Arms  ICMJE
  • Active Comparator: Biatrial radiofrequency ablation and CABG
    Biatrial radiofrequency ablation during CABG
    Intervention: Procedure: Biatrial radiofrequency ablation and CABG
  • Active Comparator: Left atrial radiofrequency ablation and CABG
    Left atrial radiofrequency ablation during CABG
    Intervention: Procedure: Left atrial radiofrequency ablation and CABG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 22, 2014)
116
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02246790
Other Study ID Numbers  ICMJE LABARFA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexander Romanov, Meshalkin Research Institute of Pathology of Circulation
Study Sponsor  ICMJE Meshalkin Research Institute of Pathology of Circulation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Meshalkin Research Institute of Pathology of Circulation
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP