Status:
COMPLETED
Impact of PREVENTIVE Substrate Ablation of Coronary Chronic Total Occlusion on Implantable cardioVerTer-Defibrillator Interventions
Lead Sponsor:
University Medical Centre Ljubljana
Conditions:
Ventricular Tachycardia
Ischemic Cardiomyopathy
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 appropria...
Detailed Description
Implantable cardioverter-defibrillators (ICDs) improve survival among patients with ischemic heart failure (HF) who have not previously had a sustained ventricular arrhythmia. However, ICD shocks that...
Eligibility Criteria
Inclusion
- Ischemic cardiomyopathy with reduced ejection fraction (EF ≤ 40%) estimated by cardiac MRI or echocardiography within 30 days before enrollment
- 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
- Implantable cardioverter-defibrillator (ICD) indication for primary prevention
- Patient has provided written informed consent
Exclusion
- Age \< 18 years or \> 85 years
- Documented sustained ventricular tachycardia before enrollment
- Class IV New York Heart Association (NYHA) heart failure
- CTOs not associated with a prior infarction in their territory
- Acute myocardial infarction (MI) or acute coronary syndrome
- Subjects with active ischemia that are eligible for revascularization
- Documented history of MI less than 6 months before enrollment
- Patients requiring chronic renal dialysis
- Thrombocytopenia or coagulopathy
- Pre-existing implantable cardioverter-defibrillator (ICD)
- Pregnancy or breastfeeding women
- Acute illness or active systemic infection
- Life expectancy less than 12 months
- Unwillingness to participate or lack of availability for follow-up
- Valvular heart disease or mechanical heart valve precluding access to the left ventricle
Key Trial Info
Start Date :
February 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03421834
Start Date
February 6 2018
End Date
January 4 2024
Last Update
January 9 2024
Active Locations (5)
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1
Klinički bolnički centar Sestre Milosrdnice
Zagreb, Croatia, HR-10000
2
General Hospital Celje
Celje, Slovenia, 3000
3
General Hospital Izola
Izola, Slovenia, 6310
4
University Medical Centre Ljubljana - Cardiology department
Ljubljana, Slovenia, 1000