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

Primary Purpose

MI Related Malignant Ventricular Arrhythmia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
unipolar or bipolar radiofrequency ablation+CABG
CABG
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MI Related Malignant Ventricular Arrhythmia focused on measuring myocardial infarction, ventricular arrhythmia, radiofrequency ablation, Coronary Artery Bypass Grafts

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xuanwu HospitalRecruiting
  • Beijing Chaoyang HospitalRecruiting
  • Beijing Anzhen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

interventional group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Morbidity of major adverse cardiovascular events
The morbidity of the major adverse cardiovascular events in 1 year after surgery

Full Information

First Posted
December 7, 2016
Last Updated
December 9, 2016
Sponsor
Beijing Anzhen Hospital
Collaborators
Xuanwu Hospital, Beijing, Beijing Chao Yang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02991170
Brief Title
Effect of Radiofrequency Ablation in Patients With Ventricular Arrhythmia Undergoing CABG
Acronym
RACAVA
Official Title
Impact of Radiofrequency Ablation Therapy in Coronary Artery Bypass Grafts Surgery on Outcomes in Patients With Myocardial Infarction Related Ventricular Arrhythmia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
Collaborators
Xuanwu Hospital, Beijing, Beijing Chao Yang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MI Related Malignant Ventricular Arrhythmia
Keywords
myocardial infarction, ventricular arrhythmia, radiofrequency ablation, Coronary Artery Bypass Grafts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing Coronary Artery Bypass Grafts
Arm Title
interventional group
Arm Type
Experimental
Arm Description
Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing unipolar or bipolar radiofrequency ablation and Coronary Artery Bypass Grafts at the same time
Intervention Type
Procedure
Intervention Name(s)
unipolar or bipolar radiofrequency ablation+CABG
Intervention Description
Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing unipolar or bipolar radiofrequency ablation and Coronary Artery Bypass Grafts at the same time
Intervention Type
Procedure
Intervention Name(s)
CABG
Intervention Description
Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing Coronary Artery Bypass Grafts
Primary Outcome Measure Information:
Title
Morbidity of potential malignant ventricular arrhythmia
Description
The morbidity of potential malignant ventricular arrhythmia in 1 year after surgery
Time Frame
1 year after surgery
Secondary Outcome Measure Information:
Title
Morbidity of major adverse cardiovascular events
Description
The morbidity of the major adverse cardiovascular events in 1 year after surgery
Time Frame
1 year after surgery
Other Pre-specified Outcome Measures:
Title
Cardiac function
Description
Change from Baseline Cardiac Function evaluated by echocardiography at 3 month, 6 month, 1 year, 2 year after surgery
Time Frame
Change from Baseline Cardiac Function at 3 month, 6 month, 1 year, 2 year after surgery
Title
Cardiac electrophysiology index
Description
Change from Baseline Cardiac Electrophysiology Index evaluated by Holter and cardiac magnetic resonance imaging or CARTO at 1 year and 2 year after surgery
Time Frame
Change from Baseline Cardiac Electrophysiology Index at 1 year and 2 year after surgery
Title
Seattle Angina Questionnaire
Description
Change from Baseline the Seattle Angina Questionnaire at 3 month, 6 month, 1 year, 2 year after surgery
Time Frame
Change from Baseline Seattle Angina Questionnaire at 3 month, 6 month, 1 year, 2 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Xuanwu Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Xu, doctor
Phone
+8613910868737
Email
lancetzkf@aliyun.com
Facility Name
Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Tian, doctor
Phone
+8613601117313
Email
doctorty2000@163.com
Facility Name
Beijing Anzhen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Yu, doctor
Phone
+8613911524101
Email
13911524101@163.com
First Name & Middle Initial & Last Name & Degree
Mingxin Gao, master
Phone
+8618611979396
Email
star880312@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Radiofrequency Ablation in Patients With Ventricular Arrhythmia Undergoing CABG

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