Epicardial Fat Pads Ablation During Coronary Surgery

Ablation of the Epicardial Fat Pads to Treat Paroxysmal Atrial Fibrillation During Coronary Artery Bypass Grafting

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02984371

Enrollment

264

Registered

2016-12-06

Start date

2016-06-30

Completion date

2018-02-28

Last updated

2016-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Ischemic Heart Disease

Keywords

atrial fibrillation, ganglionated plexi, ischemic heart disease

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.

Interventions

PROCEDURECoronary artery bypass grafting

PROCEDUREEpicardial ganglionated plexi ablation

PROCEDUREimplantable loop recorder

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Russia

Contacts

Primary ContactAlexander Romanov, MD, PhD

abromanov@mail.ru+73833327655

Backup ContactEvgeny Pokushalov, MD, PhD

+73833327655

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026