MI Related Malignant Ventricular Arrhythmia Clinical Trial
— RACAVAOfficial title:
Impact of Radiofrequency Ablation Therapy in Coronary Artery Bypass Grafts Surgery on Outcomes in Patients With Myocardial Infarction Related Ventricular Arrhythmia
| Verified date | December 2016 |
| Source | Beijing Anzhen Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Beijing Municipal Health Bureau |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 180 |
| Est. completion date | December 2018 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 45 Years to 75 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Anzhen Hospital | Beijing | Beijing |
| China | Beijing Chaoyang Hospital | Beijing | Beijing |
| China | Xuanwu Hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Beijing Anzhen Hospital | Beijing Chao Yang Hospital, Xuanwu Hospital, Beijing |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Cardiac function | 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 | No |
| Other | Cardiac electrophysiology index | 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 | No |
| Other | Seattle Angina Questionnaire | 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 | No |
| Primary | Morbidity of potential malignant ventricular arrhythmia | The morbidity of potential malignant ventricular arrhythmia in 1 year after surgery | 1 year after surgery | No |
| Secondary | Morbidity of major adverse cardiovascular events | The morbidity of the major adverse cardiovascular events in 1 year after surgery | 1 year after surgery | No |