Epicardial Fat Pads Ablation During Coronary Surgery

December 2, 2016 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

264

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • Recruiting
        • State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
        • Principal Investigator:
          • Alexander Romanov, MD, PhD
        • Sub-Investigator:
          • Alexander Cherniavskiy, MD, PhD
      • Tomsk, Russian Federation
        • Recruiting
        • Cardiology Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Coronary artery bypass grafting + epicardial ganglionated plexi ablation
Procedure: Coronary artery bypass grafting
Procedure: Epicardial ganglionated plexi ablation
Procedure: implantable loop recorder
Active Comparator: Group 2
Coronary artery bypass grafting
Procedure: Coronary artery bypass grafting
Procedure: implantable loop recorder

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASTR_0789

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Coronary artery bypass grafting

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe