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Epicardial Fat Pads Ablation During Coronary Surgery

NCT ID: NCT02984371

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-02-28

Brief Summary

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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

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Conditions

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Atrial Fibrillation Ischemic Heart Disease

Keywords

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atrial fibrillation ganglionated plexi ischemic heart disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group 1

Coronary artery bypass grafting + epicardial ganglionated plexi ablation

Group Type EXPERIMENTAL

Coronary artery bypass grafting

Intervention Type PROCEDURE

Epicardial ganglionated plexi ablation

Intervention Type PROCEDURE

implantable loop recorder

Intervention Type PROCEDURE

Group 2

Coronary artery bypass grafting

Group Type ACTIVE_COMPARATOR

Coronary artery bypass grafting

Intervention Type PROCEDURE

implantable loop recorder

Intervention Type PROCEDURE

Interventions

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Coronary artery bypass grafting

Intervention Type PROCEDURE

Epicardial ganglionated plexi ablation

Intervention Type PROCEDURE

implantable loop recorder

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Novosibirsk, , Russia

Site Status RECRUITING

Cardiology Research Institute

Tomsk, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Alexander Romanov, MD, PhD

Role: CONTACT

Phone: +73833327655

Email: [email protected]

Evgeny Pokushalov, MD, PhD

Role: CONTACT

Phone: +73833327655

Facility Contacts

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Evgeny Pokushalov, MD, PhD

Role: primary

Boris Kozlov, MD, PhD

Role: primary

Other Identifiers

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ASTR_0789

Identifier Type: -

Identifier Source: org_study_id