The Assessment of Progression of Paroxysmal Atrial Fibrillation in Patients After Coronary Artery Bypass Grafting Through Continuous Subcutaneous Monitoring
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Progression of atrial fibrillation
Study Overview
Brief Summary
The aim of this study is a comparative evaluation of progression of paroxysmal atrial fibrillation in patients with coronary artery disease after isolated CABG and CABG combined with pulmonary vein isolation.
Hypothesis of the study - patients with paroxysmal atrial fibrillation and coronary artery disease after CABG in combination with isolation of the pulmonary veins have a better outcomes for the progression of AF compared with patients undergoing isolated CABG.
Detailed Description
This is a single blinded prospective randomized study involving 72 patients with paroxysmal AF and coronary artery disease. 72 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure by 10% in the CABG + pulmonary veins isolation group over isolated CABG group. Patients are divided into two groups, group I - isolated CABG (36 patients), and group II - CABG and pulmonary veins isolation (36 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 pulmonary vein isolation. Subcutaneous cardiac monitor is implanted to all patients for cardiac rhythm monitoring.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •American College of Cardiology (ACC)/ American Heart Association (AHA) -Indications for CABG
- •At least 2 ECG-verified (12-channel ECG, Holter telemetry) symptomatic paroxysmal atrial fibrillation episodes 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
Arms & Interventions
CABG+pulmonary vein isolation
CABG+pulmonary vein isolation procedure
Intervention: CABG+Pulmonary vein isolation procedure (Procedure)
Isolated CABG
Isolated CABG procedure
Intervention: Isolated CABG (Procedure)
Outcomes
Primary Outcomes
Progression of atrial fibrillation
Time Frame: up to 36 months
Combined indicator consist of recurrence of AF, increased frequency of AF, progression to persistent AF. Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds. Patients with AF\>0.5% were classified as non-responders.
Secondary Outcomes
- Cardiovascular events(Within three years after surgery)
- Hospitalization due to atrial fibrillation after surgery(Within three years after surgery)
Investigators
Alexander Romanov
Meshalkin Research Institute of Pathology of Circulation
Meshalkin Research Institute of Pathology of Circulation