NCT02991170

Brief Summary

Patients with myocardial infarction related potential malignant ventricular arrhythmia have high risk of sudden death. The aim of this clinical trial is evaluating therapeutic efficacy of unipolar or bipolar radiofrequency ablation in Coronary Artery Bypass Grafts (CABG) Surgery, which can reduce myocardial ischemia and block reentry circuits of ventricular arrhythmia at the same time. The observation indexes include the morbidity of potential malignant ventricular arrhythmia and major adverse cardiovascular events in mid-long-term after CABG surgery.

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
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 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

January 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

2.9 years

First QC Date

December 7, 2016

Last Update Submit

December 9, 2016

Conditions

MI Related Malignant Ventricular Arrhythmia

Keywords

myocardial infarctionventricular arrhythmiaradiofrequency ablationCoronary Artery Bypass Grafts

Outcome Measures

Primary Outcomes (1)

  • Morbidity of potential malignant ventricular arrhythmia

    The morbidity of potential malignant ventricular arrhythmia in 1 year after surgery

    1 year after surgery

Secondary Outcomes (1)

  • Morbidity of major adverse cardiovascular events

    1 year after surgery

Other Outcomes (3)

  • Cardiac function

    Change from Baseline Cardiac Function at 3 month, 6 month, 1 year, 2 year after surgery

  • Cardiac electrophysiology index

    Change from Baseline Cardiac Electrophysiology Index at 1 year and 2 year after surgery

  • Seattle Angina Questionnaire

    Change from Baseline Seattle Angina Questionnaire at 3 month, 6 month, 1 year, 2 year after surgery

Study Arms (2)

control group

ACTIVE COMPARATOR

Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing Coronary Artery Bypass Grafts

Procedure: CABG

interventional group

EXPERIMENTAL

Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing unipolar or bipolar radiofrequency ablation and Coronary Artery Bypass Grafts at the same time

Procedure: unipolar or bipolar radiofrequency ablation+CABG

Interventions

unipolar or bipolar radiofrequency ablation+CABGPROCEDURE

Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing unipolar or bipolar radiofrequency ablation and Coronary Artery Bypass Grafts at the same time

interventional group
CABGPROCEDURE

Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing Coronary Artery Bypass Grafts

control group

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients have been receiving coronary artery bypass grafts from 2015.1-2017.12
  • The patients had old myocardial infarction related potential malignant ventricular arrhythmia
  • Anti-arrhythmic drug treatment is invalid
  • All enrolled patients must being signed the informed consent

You may not qualify if:

  • Severe heart failure( ejection fraction under 35%)
  • Patients with acute myocardial infarction
  • Patients with ICD implanted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Xuanwu Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Cardiac Surgery, Principal Investigator,Clinical Professor

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 13, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

December 13, 2016

Record last verified: 2016-12

Locations

CN(3)