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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991170
Recruitment Status : Unknown
Verified December 2016 by Yang Yu, Beijing Anzhen Hospital.
Recruitment status was:  Recruiting
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Collaborators:
Xuanwu Hospital, Beijing
Beijing Chao Yang Hospital
Information provided by (Responsible Party):
Yang Yu, Beijing Anzhen Hospital

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.

Condition or disease Intervention/treatment Phase
MI Related Malignant Ventricular Arrhythmia Procedure: unipolar or bipolar radiofrequency ablation+CABG Procedure: CABG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Radiofrequency Ablation Therapy in Coronary Artery Bypass Grafts Surgery on Outcomes in Patients With Myocardial Infarction Related Ventricular Arrhythmia
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Morbidity of potential malignant ventricular arrhythmia [ Time Frame: 1 year after surgery ]
    The morbidity of potential malignant ventricular arrhythmia in 1 year after surgery


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991170


Locations
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China, Beijing
Xuanwu Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Dong Xu, doctor    +8613910868737    lancetzkf@aliyun.com   
Beijing Chaoyang Hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Ying Tian, doctor    +8613601117313    doctorty2000@163.com   
Beijing Anzhen Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Yang Yu, doctor    +8613911524101    13911524101@163.com   
Contact: Mingxin Gao, master    +8618611979396    star880312@126.com   
Sponsors and Collaborators
Beijing Anzhen Hospital
Xuanwu Hospital, Beijing
Beijing Chao Yang Hospital
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Responsible Party: Yang Yu, Deputy Director of Cardiac Surgery, Principal Investigator,Clinical Professor, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT02991170    
Other Study ID Numbers: XMLX201504
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yang Yu, Beijing Anzhen Hospital:
myocardial infarction
ventricular arrhythmia
radiofrequency ablation
Coronary Artery Bypass Grafts
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes