Impact of PREVENTIVE Substrate Ablation of Coronary Chronic Total Occlusion on Implantable cardioVerTer-Defibrillator Interventions

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Centre Ljubljana

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