Effect of Radiofrequency Ablation in Patients With Ventricular Arrhythmia Undergoing CABG (RACAVA)

December 9, 2016 updated by: Yang Yu, Beijing Anzhen Hospital

Impact of Radiofrequency Ablation Therapy in Coronary Artery Bypass Grafts Surgery on Outcomes in Patients With Myocardial Infarction Related Ventricular Arrhythmia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Beijing Anzhen Hospital
        • Contact:
        • Contact:
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing ChaoYang Hospital
        • Contact:
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Xuanwu Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing Coronary Artery Bypass Grafts
Procedure: CABG
Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing Coronary Artery Bypass Grafts
Experimental: interventional group
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
Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing unipolar or bipolar radiofrequency ablation and Coronary Artery Bypass Grafts at the same time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity of potential malignant ventricular arrhythmia
Time Frame: 1 year after surgery
The morbidity of potential malignant ventricular arrhythmia in 1 year after surgery
1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity of major adverse cardiovascular events
Time Frame: 1 year after surgery
The morbidity of the major adverse cardiovascular events in 1 year after surgery
1 year after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac function
Time Frame: Change from Baseline Cardiac Function at 3 month, 6 month, 1 year, 2 year after surgery
Change from Baseline Cardiac Function evaluated by echocardiography at 3 month, 6 month, 1 year, 2 year after surgery
Change from Baseline Cardiac Function at 3 month, 6 month, 1 year, 2 year after surgery
Cardiac electrophysiology index
Time Frame: Change from Baseline Cardiac Electrophysiology Index at 1 year and 2 year after surgery
Change from Baseline Cardiac Electrophysiology Index evaluated by Holter and cardiac magnetic resonance imaging or CARTO at 1 year and 2 year after surgery
Change from Baseline Cardiac Electrophysiology Index at 1 year and 2 year after surgery
Seattle Angina Questionnaire
Time Frame: Change from Baseline Seattle Angina Questionnaire at 3 month, 6 month, 1 year, 2 year after surgery
Change from Baseline the Seattle Angina Questionnaire at 3 month, 6 month, 1 year, 2 year after surgery
Change from Baseline Seattle Angina Questionnaire at 3 month, 6 month, 1 year, 2 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Collaborators

Xuanwu Hospital, Beijing
Beijing Chao Yang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (Estimate)

December 13, 2016

Study Record Updates

Last Update Posted (Estimate)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 9, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XMLX201504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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