NCT03421834Completed
Impact of PREVENTIVE Substrate Ablation of Coronary Chronic Total Occlusion on Implantable cardioVerTer-Defibrillator Interventions
Impact of PREVENTIVE Substrate Catheter Ablation on Implantable cardioVerter-defibrillaTor Interventions in Patients With Ischaemic Cardiomyopathy and Infarct-related Coronary Chronic Total Occlusion
Source: ClinicalTrials.gov · Last updated 9 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 25 Jan 2018
- Start date
- 6 Feb 2018
- Primary completion date
- 4 Jan 2024
- Lead sponsor
- University Medical Centre Ljubljana
- Diseases
- Heart failure
- NCT number
- NCT03421834
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 6 Feb 2018 to the primary completion date, 4 Jan 2024
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- CTOs not associated with a prior infarction in their territory
- Documented history of MI less than 6 months before enrollment
Other illness
- Class IV New York Heart Association (NYHA) heart failure
- Acute myocardial infarction (MI) or acute coronary syndrome
- Acute illness or active systemic infection
- Valvular heart disease or mechanical heart valve precluding access to the left ventricle
Age
- Age \< 18 years or \> 85 years
Other
- Documented sustained ventricular tachycardia before enrollment
- Subjects with active ischemia that are eligible for revascularization
- Patients requiring chronic renal dialysis
- Thrombocytopenia or coagulopathy
- Pre-existing implantable cardioverter-defibrillator (ICD)
- Pregnancy or breastfeeding women
- Life expectancy less than 12 months
- Unwillingness to participate or lack of availability for follow-up
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinički Bolnički Centar Sestre Milosrdnice Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| General Hospital Celje Coordinator of this site? Confirm its status | Celje | Slovenia | Unknown status |
| General Hospital Izola Coordinator of this site? Confirm its status | Izola | Slovenia | Unknown status |
| University Medical Centre Ljubljana - Cardiology department Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
| University Medical Centre Ljubljana - Cardiovascular surgery department Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.