NCT03857711

Brief Summary

To compare prophylactic strategies of atrial fibrillation in patients with CAD and without AF.

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
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

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

September 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

February 22, 2019

Last Update Submit

February 4, 2020

Conditions

Arrhythmias, CardiacCardiovascular DiseasesPostoperative Atrial FibrillationMyocardial Ischemia

Keywords

Bipolar radiofrequency ablationAtrial Fibrillation New OnsetCABGCoronary artery diseasePostoperative atrial fibrillation

Outcome Measures

Primary Outcomes (2)

  • Incidence of atrial fibrillation after CABG

    Through study completion, an average of 1 year

  • Major cardiovascular and cerebral events (MACCE), including death, nonfatal myocardial infarction, repeated revascularization using PCI or CABG, transitory ischemic attack (TIA) or stroke.

    Through study completion, an average of 1 year

Secondary Outcomes (8)

  • Sinus rhythm at the time of discharge of the patient from the hospital

    Through study completion, an average of 1 year

  • Duration of mechanical ventilation

    Through study completion, an average of 1 year

  • Incidence of implantation of the pacemaker

    Through study completion, an average of 1 year

  • Volume of intraoperative bleeding

    Through study completion, an average of 1 year

  • Time of CBP

    Through study completion, an average of 1 year

  • +3 more secondary outcomes

Study Arms (4)

Conventional CABG

ACTIVE COMPARATOR

Coronary artery bypass grafting (CABG) treatment (CABG group,n=70)

Procedure: Conventional CABG

CABG+ PVI

ACTIVE COMPARATOR

CABG + prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation (CABG +PVI group, n=70)

Procedure: CABG+ PVI

CABG+ PVI+amiodarone

ACTIVE COMPARATOR

CABG+ prophylactic epicardial bipolar radiofreaquency pulmonary veins isolation + amiodarone (CABG +PVI+ class III antiarrhythmic drug- amiodarone, group, n=70)

Procedure: CABG+ PVI+amiodarone

CABG+amiodarone

ACTIVE COMPARATOR

CABG+class III antiarrhythmic drug- amiodarone, group, n=70

Procedure: CABG+amiodarone

Interventions

Conventional CABGPROCEDURE

Coronary artery bypass grafting

Conventional CABG
CABG+ PVIPROCEDURE

CABG+ prophylactic epicardial bipolar radiofrequency isolation of the pulmonary veins

CABG+ PVI
CABG+ PVI+amiodaronePROCEDURE

CABG+PVI+amiodarone (CABG+RFA + class III antiarrhythmic drug- amiodarone)

CABG+ PVI+amiodarone
CABG+amiodaronePROCEDURE
CABG+amiodarone

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients must have signed an informed consent.
  • patients had indications for two or more coronary arteries to be bypassed
  • no history of AF

You may not qualify if:

  • acute coronary syndrome
  • previous CABG.
  • a significant decrease in the contractile function of the heart (EF \<40%)
  • significant heart valve disease requiring surgical repair
  • long-standing persistent, persistent, or paroxysmal forms of atrial fibrillation
  • respiratory failure
  • left ventricular aneurysm requiring surgical correction
  • chronic renal failure (≤60 mL/min/1⋅73 m2)
  • chronic diseases that make a significant contribution to the prognosis of life (e.g. oncology)
  • participation in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Federal Centre of High Medical Technologies of the RF Ministry of Public Health, Kaliningrad, Russia.

Kaliningrad, 236035, Russia

RECRUITING

A.V. Vishnevsky National Medical Research Center of Surgery.

Moscow, 117997, Russia

RECRUITING

MeSH Terms

Conditions

Arrhythmias, CardiacCardiovascular DiseasesMyocardial IschemiaCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Amiran Sh. Revishvili

    A.V. Vishnevsky National Medical Research Center of Surgery. Moscow. Russian Federation.

    STUDY CHAIR

Central Study Contacts

Amiran Sh. Revishvili

CONTACT

+7 (499) 236-72-90

Vadim A. Popov

CONTACT

+7 9166706609drpopov@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 22, 2019

First Posted

February 28, 2019

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2022

Last Updated

February 6, 2020

Record last verified: 2019-02

Locations

RU(2)