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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 January 2024
• Main ID: NCT03421834
• Date of registration: 25/01/2018
• Prospective Registration: Yes
• Primary sponsor: University Medical Centre Ljubljana
• Public title: Impact of PREVENTIVE Substrate Ablation of Coronary Chronic Total Occlusion on Implantable cardioVerTer-Defibrillator Interventions PREVENTIVE VT
• Scientific title: Impact of PREVENTIVE Substrate Catheter Ablation on Implantable cardioVerter-defibrillaTor Interventions in Patients With Ischaemic Cardiomyopathy and Infarct-related Coronary Chronic Total Occlusion
• Date of first enrolment: February 6, 2018
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03421834
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Croatia, Slovenia

Contacts

• Name: Andrej Pernat, Prof.
• Affiliation: University Medical Centre Ljubljana (Slovenia)

• Name: David Zizek, Assist. Prof.
• Affiliation: University Medical Centre Ljubljana (Slovenia)

• Name: Matjaz Sinkovec, Prof.
• Affiliation: University Medical Centre Ljubljana (Slovenia)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ventricular Tachycardia

Ischemic Cardiomyopathy

Intervention(s)

Drug: Optimal medical treatment

Procedure: Catheter ablation of ventricular tachycardia

Primary Outcome(s)

Time to first event comprising appropriate ICD therapy and unplanned hospital admission for symptomatic ventricular tachycardia (VT)/ ventricular fibrillation (VF) [Time Frame: From randomization until official study end or drop-out, patients will be followed and assessed at least 24 months.]

Secondary Outcome(s)

Time to unplanned hospital admission for symptomatic ventricular tachycardia (VT)/ ventricular fibrillation (VF) [Time Frame: At least 24 months after enrolment]

Cardio-vascular mortality [Time Frame: At least 24 months after enrolment]

Changes in quality of life using the EQ-5D questionnaire [Time Frame: At least 24 months after enrolment]

Psychometric evaluation of ICD shock-related anxiety using The Florida Shock Anxiety Scale (FSAS) [Time Frame: At least 24 months after enrolment]

Time to electrical storm [Time Frame: At least 24 months after enrolment]

Time to unplanned cardiac hospital admission [Time Frame: At least 24 months after enrolment]

Incidence of appropriate ICD therapy [Time Frame: At least 24 months after enrolment]

Time to appropriate ICD therapy [Time Frame: At least 24 months after enrolment]

Secondary ID(s)

PREVENTIVE VT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors