Epicardial Fat Pads Ablation During Coronary Surgery

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 2

Conditions: Ischemic Heart Disease; Atrial Fibrillation

Treatments: Procedure: Coronary artery bypass grafting; Procedure: implantable loop recorder; Procedure: Epicardial ganglionated plexi ablation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02984371

ASTR_0789

Details and patient eligibility

About

The aim of this prospective randomized study was to assess the efficacy of ablation of the ganglionated plexi localized in the epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.

Enrollment: 264 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of paroxysmal atrial fibrillation (recurrent episodes for at least 1 years, with 2 documented episodes over the last 6 months)
• Indication for cardiac surgery (e.g. coronary artery bypass grafting, valve repair/replacement) according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for cardiac surgery

Exclusion criteria

Previous heart surgery or atrial fibrillation ablation procedure Emergency coronary artery bypass grafting Unstable angina or heart failure Persistent atrial fibrillation Planned maze procedure or pulmonary vein isolation Unwillingness to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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264 participants in 2 patient groups

Group 1

Experimental group

Description:

Coronary artery bypass grafting + epicardial ganglionated plexi ablation

Treatment:

Procedure: Epicardial ganglionated plexi ablation

Procedure: implantable loop recorder

Procedure: Coronary artery bypass grafting

Group 2

Active Comparator group

Description:

Coronary artery bypass grafting

Treatment:

Procedure: implantable loop recorder

Procedure: Coronary artery bypass grafting