Coronary Artery Disease, Implantable Cardioverter-Defibrillator, Ventricular Tachycardia
Conditions
Keywords
Ablation, Ventricular tachycardia, coronary artery disease, Implantable cardioverter defibrillator interventions
Brief summary
The aim of this study is to assess the role of ablation in appropriate ICD interventions reduction in patients with coronary artery disease. The group will consist of 200 patients with implanted ICD and appropriate intervention in the 3 months prior to enrollment. The patients will be randomized into ablation arm and conventional treatment. Number of appropriate ICD interventions is the primary endpoint of this study. All patients will have control follow-up visits every 3 months. The follow-up will be based on ICD memory.
Interventions
PROCEDUREablation
Sponsors
National Institute of Cardiology, Warsaw, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Coronary Artery Disease * ICD implanted * Appropriate ICD intervention during the 3 months prior to enrollment * Coronary angiography during the 6 months prior to enrollment * Possible revascularization * Age over 18 years * Signed informed consent
Exclusion criteria
* Age less then 18 years * Pregnancy * Active participation in other trial * Heart failure (NYHA IV) * Contraindications for ablation procedure: i.e. left ventricular thrombus, artificial aortic or mitral valve, no vascular access. * Monomorphic, incessant, ventricular tachycardia * Revascularization or other cardio-surgical procedure scheduled in the next 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of appropriate ICD interventions | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall mortality | — |
| Cardiac mortality | — |
| Hospitalization due to arrhythmia or heart failure | — |
| Quality of life | — |
Countries
Poland
Outcome results
None listed