Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT03819504
Eligibility Criteria:
Inclusion Criteria:
* Patients with structural heart disease (ischemic and non-ischemic cardiomyopathy, previous surgery for congenital heart disease)
* Implanted ICD or CRT-D (cardiac resynchronization therapy defibrillator)
* Prior ≥1 catheter ablation procedure for monomorphic VT
* VT recurrence early (\<12 months) after the last ablation with at least 2 episodes of recurrent VT, including 1 episode while on amiodarone (if not contraindicated)
* Age ≥30 years
* Signed an IRB-approved (Institutional Review Board) written informed consent
Exclusion Criteria:
* Acute myocardial infarction or recent percutaneous coronary intervention (PCI) or cardiac surgery (\<3 months)
* Primary electrical disease (channelopathy)
* Reversible cause of VT (e.g. drug-induced, intoxications, etc)
* Pregnancy or breastfeeding
* Chronic heart failure New York Heart Association (NYHA) Class IV
* Serious comorbidities with presumed life expectancy less than one year
* Significant peripheral artery disease precluding retrograde aortic mapping
* History of chest radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT03819504
Study Brief:
Protocol Section:
NCT03819504