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Epicardial Fat Pads Ablation During Coronary Surgery

Primary Purpose

Atrial Fibrillation, Ischemic Heart Disease

Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Coronary artery bypass grafting
Epicardial ganglionated plexi ablation
implantable loop recorder
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, ganglionated plexi, ischemic heart disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • State Research Institute of CIrculation Pathology Novosibirsk, Russian FederationRecruiting
  • Cardiology Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Coronary artery bypass grafting + epicardial ganglionated plexi ablation

Coronary artery bypass grafting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

atrial fibrillation burden
incidence of congestive heart failure
incidence of sustained ventricular arrhythmias
rehospitalization
stroke or transient ischemic attack
number of Deaths

Full Information

First Posted
December 2, 2016
Last Updated
December 2, 2016
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02984371
Brief Title
Epicardial Fat Pads Ablation During Coronary Surgery
Official Title
Ablation of the Epicardial Fat Pads to Treat Paroxysmal Atrial Fibrillation During Coronary Artery Bypass Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Ischemic Heart Disease
Keywords
atrial fibrillation, ganglionated plexi, ischemic heart disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Coronary artery bypass grafting + epicardial ganglionated plexi ablation
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Coronary artery bypass grafting
Intervention Type
Procedure
Intervention Name(s)
Coronary artery bypass grafting
Intervention Type
Procedure
Intervention Name(s)
Epicardial ganglionated plexi ablation
Intervention Type
Procedure
Intervention Name(s)
implantable loop recorder
Primary Outcome Measure Information:
Title
Recurrence of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug
Time Frame
12 month
Secondary Outcome Measure Information:
Title
atrial fibrillation burden
Time Frame
12 month
Title
incidence of congestive heart failure
Time Frame
12 month
Title
incidence of sustained ventricular arrhythmias
Time Frame
12 month
Title
rehospitalization
Time Frame
12 month
Title
stroke or transient ischemic attack
Time Frame
12 month
Title
number of Deaths
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Romanov, MD, PhD
Phone
+73833327655
Email
abromanov@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Evgeny Pokushalov, MD, PhD
Phone
+73833327655
Facility Information:
Facility Name
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
Phone
+79139254858
Email
E.Pokushalov@gmail.com
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alexander Romanov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alexander Cherniavskiy, MD, PhD
Facility Name
Cardiology Research Institute
City
Tomsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boris Kozlov, MD, PhD
Phone
+7(3822) 56 12 32
Email
cardio@cardio-tomsk.ru

12. IPD Sharing Statement

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Epicardial Fat Pads Ablation During Coronary Surgery

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