Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Biatrial radiofrequency ablation and CABG Procedure: Left atrial radiofrequency ablation and CABG Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Surgical Ablation of Long-standing Persistent Atrial Fibrillation During CABG Through Continuous Subcutaneous Monitoring
Study Start Date : December 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Biatrial radiofrequency ablation and CABG
Biatrial radiofrequency ablation during CABG
 Procedure: Biatrial radiofrequency ablation and CABG
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant biatrial RFA during CPB.
Active Comparator: Left atrial radiofrequency ablation and CABG
Left atrial radiofrequency ablation during CABG
 Procedure: Left atrial radiofrequency ablation and CABG
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant left atrial RFA during CPB.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Cardiovascular events [ Time Frame: Within three years after surgery ]
    All cases of stroke, cardiac infarction, thromboembolism, bleeding and death


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246790


Contacts
Layout table for location contacts
Contact: Sardor Rakhmonov +79231278557 sardor5507@mail.ru

Locations
Layout table for location information
Russian Federation
Meshalkin State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Sardor Rakhmonov    +79231278557    sardor5507@mail.ru   
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Alexander Romanov, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02246790     History of Changes
Other Study ID Numbers: LABARFA
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015
Keywords provided by Alexander Romanov, Meshalkin Research Institute of Pathology of Circulation:
ablation, CABG
Long-standing persistent Atrial Fibrillation
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Atrial Fibrillation
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Arrhythmias, Cardiac
Pathologic Processes