Surgical Ablation of Long-standing Persistent AF During CABG
LABARFA
1 other identifier
interventional
116
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 coronary-artery-disease
Started Dec 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2014
CompletedFirst Posted
Study publicly available on registry
September 23, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedNovember 13, 2015
November 1, 2015
1 year
September 19, 2014
November 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to 36 months
Secondary Outcomes (1)
Cardiovascular events
Within three years after surgery
Study Arms (2)
Biatrial radiofrequency ablation and CABG
ACTIVE COMPARATORBiatrial radiofrequency ablation during CABG
Left atrial radiofrequency ablation and CABG
ACTIVE COMPARATORLeft atrial radiofrequency ablation during CABG
Interventions
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant biatrial RFA during CPB.
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant left atrial RFA during CPB.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Meshalkin State Research Institute of Circulation Pathology
Novosibirsk, 630055, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Meshalkin Research Institute of Pathology of Circulation
Study Record Dates
First Submitted
September 19, 2014
First Posted
September 23, 2014
Study Start
December 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2017
Last Updated
November 13, 2015
Record last verified: 2015-11