Surgical Ablation of Long-standing Persistent AF During CABG

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Biatrial radiofrequency ablation and CABG

Biatrial radiofrequency ablation during CABG

Group Type ACTIVE_COMPARATOR

Biatrial radiofrequency ablation and CABG

Intervention Type PROCEDURE

Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant biatrial RFA during CPB.

Left atrial radiofrequency ablation and CABG

Left atrial radiofrequency ablation during CABG

Group Type ACTIVE_COMPARATOR

Left atrial radiofrequency ablation and CABG

Intervention Type PROCEDURE

Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant left atrial RFA during CPB.

Interventions

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Biatrial radiofrequency ablation and CABG

Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant biatrial RFA during CPB.

Intervention Type PROCEDURE

Left atrial radiofrequency ablation and CABG

Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant left atrial RFA during CPB.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No