Epicardial Fat Pads Ablation During Coronary Surgery

Phase 2

• Conditions: Atrial Fibrillation; Ischemic Heart Disease
• Interventions: Procedure: Coronary artery bypass grafting; Procedure: Epicardial ganglionated plexi ablation; Procedure: implantable loop recorder

• Registration Number: NCT02984371
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Status Verified: 2016-12
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-02
• Last Update Submitted: 2016-12-02
• Study First Posted: 2016-12-06
• Last Update Posted: 2016-12-06
• Primary Completion: 2017-12
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Coronary artery bypass grafting	Coronary artery bypass grafting + epicardial ganglionated plexi ablation
Group 1	implantable loop recorder	Coronary artery bypass grafting + epicardial ganglionated plexi ablation
Group 2	Coronary artery bypass grafting	Coronary artery bypass grafting
Group 1	Epicardial ganglionated plexi ablation	Coronary artery bypass grafting + epicardial ganglionated plexi ablation
Group 2	implantable loop recorder	Coronary artery bypass grafting

Primary Outcome Measures

Name	Time	Method
Recurrence of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug	12 month

Secondary Outcome Measures

Name	Time	Method
stroke or transient ischemic attack	12 month
atrial fibrillation burden	12 month
incidence of congestive heart failure	12 month
incidence of sustained ventricular arrhythmias	12 month
rehospitalization	12 month
number of Deaths	12 month

Trial Locations

Locations (2)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation; 🇷🇺 Novosibirsk, Russian Federation

Cardiology Research Institute; 🇷🇺 Tomsk, Russian Federation