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Clinical trial

Impact of PREVENTIVE Substrate Catheter Ablation on Implantable cardioVerter-defibrillaTor Interventions in Patients With Ischaemic Cardiomyopathy and Infarct-related Coronary Chronic Total Occlusion

ID
Name
PREVENTIVE VT
Description
The aim of this study is to assess whether preventive substrate ablation of chronic total occlusion infarct-related artery (CTO-IRA) area in heart failure (HF) patients correlates with lower appropriate implantable cardiac defibrillator (ICD) therapies. In addition, the purpose of the study is to determine whether prophylactic substrate ablation at the time of primary ICD implantation in high-risk ischemic patients affects unplanned hospitalization, HF progression, and quality of life.
Trial arms
Trial start
2018-02-06
Estimated PCD
2024-01-04
Trial end
2024-01-04
Status
Completed
Treatment
Catheter ablation of ventricular tachycardia
Catheter ablation with a uniform mapping system, procedural endpoint, and definition of acute procedural success.
Arms:
Prophylactic VT ablation prior to ICD implantation
Optimal medical treatment
Optimal guidelines-based heart failure treatment and antiarrhythmic drugs. Antiarrhythmics will be avoided if possible in the ablation group.
Arms:
ICD implantation and optimal medical treatment, Prophylactic VT ablation prior to ICD implantation
Size
60
Primary endpoint
Time to first event comprising appropriate ICD therapy and unplanned hospital admission for symptomatic ventricular tachycardia (VT)/ ventricular fibrillation (VF)
From randomization until official study end or drop-out, patients will be followed and assessed at least 24 months.
Eligibility criteria
Inclusion Criteria: 1. Ischemic cardiomyopathy with reduced ejection fraction (EF ≤ 40%) estimated by cardiac MRI or echocardiography within 30 days before enrollment 2. Coronary Chronic Total Occlusion (CTO) associated with a previous MI confirmed by coronary angiography and late gadolinium enhancement MRI or myocardial perfusion imaging within 30 days before enrollment 3. Implantable cardioverter-defibrillator (ICD) indication for primary prevention 4. Patient has provided written informed consent Exclusion Criteria: 1. Age \< 18 years or \> 85 years 2. Documented sustained ventricular tachycardia before enrollment 3. Class IV New York Heart Association (NYHA) heart failure 4. CTOs not associated with a prior infarction in their territory 5. Acute myocardial infarction (MI) or acute coronary syndrome 6. Subjects with active ischemia that are eligible for revascularization 7. Documented history of MI less than 6 months before enrollment 8. Patients requiring chronic renal dialysis 9. Thrombocytopenia or coagulopathy 10. Pre-existing implantable cardioverter-defibrillator (ICD) 11. Pregnancy or breastfeeding women 12. Acute illness or active systemic infection 13. Life expectancy less than 12 months 14. Unwillingness to participate or lack of availability for follow-up 15. Valvular heart disease or mechanical heart valve precluding access to the left ventricle
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-01-09

1 organization

1 product

2 indications

Organization
University Medical Centre Ljubljana
Product
Optimal medical treatment
Indication
Ventricular Tachycardia
Indication
Ischemic Cardiomyopathy