NCT02984371

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for phase_2 atrial-fibrillation

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

1.5 years

First QC Date

December 2, 2016

Last Update Submit

December 2, 2016

Conditions

Atrial FibrillationIschemic Heart Disease

Keywords

atrial fibrillationganglionated plexiischemic heart disease

Outcome Measures

Primary Outcomes (1)

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

    12 month

Secondary Outcomes (6)

  • atrial fibrillation burden

    12 month

  • incidence of congestive heart failure

    12 month

  • incidence of sustained ventricular arrhythmias

    12 month

  • rehospitalization

    12 month

  • stroke or transient ischemic attack

    12 month

  • +1 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL

Coronary artery bypass grafting + epicardial ganglionated plexi ablation

Procedure: Coronary artery bypass graftingProcedure: Epicardial ganglionated plexi ablationProcedure: implantable loop recorder

Group 2

ACTIVE COMPARATOR

Coronary artery bypass grafting

Procedure: Coronary artery bypass graftingProcedure: implantable loop recorder

Interventions

Coronary artery bypass graftingPROCEDURE
Group 1Group 2
Epicardial ganglionated plexi ablationPROCEDURE
Group 1
implantable loop recorderPROCEDURE
Group 1Group 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Novosibirsk, 630055, Russia

RECRUITING

Cardiology Research Institute

Tomsk, Russia

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationMyocardial Ischemia

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Central Study Contacts

Alexander Romanov, MD, PhD

CONTACT

+73833327655abromanov@mail.ru

Evgeny Pokushalov, MD, PhD

CONTACT

+73833327655

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 6, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2017

Study Completion

February 1, 2018

Last Updated

December 6, 2016

Record last verified: 2016-12

Locations

RU(2)