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 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT04246450
Eligibility Criteria:
Inclusion Criteria:
ALL of the following criteria must be fulfilled:
1. Dilated cardiomyopathy diagnosis based on the ESC proposed criteria1: Dilation based on left ventricular end-diastolic diameter or volume \>2SD larger than age, gender, and body surface area adjusted normal values, hypokinesia based on left ventricular ejection fraction ≤50%, not attributable to loading conditions or coronary artery disease. In cases of LVEF\<45%, otherwise unexplained, and no evident ventricular dilation, the diagnosis of hypokinetic, nondilated CMP will be made
2. Patients will have to have been diagnosed \>6 months prior to enrolment in order to exclude reversible myocarditis cases
3. Be on sinus rhythm or with paroxysmal atrial fibrillation to facilitate noninvasive risk factor (NIRF) presence assessment
4. Age \>18 years and \<80 years
5. On optimal medical therapy for at least 3 months
Exclusion Criteria:
A patient will be excluded from the study if any of the following criteria are present:
1. Significant ventricular extrasystole burden (\>10,000/24hrs or \>10% PVCs) on 24hr ambulatory ECG (PVC-induced cardiomyopathy)38, 39, persisting even after all pharmacologic and/or interventional (ablation) attempts
2. Permanent atrial fibrillation
3. More than moderate left-sided valvular heart disease
4. Epicardial vessel lumen stenoses \>70% detected on coronary angiogram36 in a major coronary artery
5. Expected survival \<12months
6. Pregnancy (planned and accidental)
7. Stage IIIb chronic kidney disease (estimated glomerular filtration rate \<30ml/hr). This mainly relates to the non-tachycardic SCD mechanisms in this population (bradycardia/pulseless electrical activity)40-42, not amenable to antitachycardic ICD interventions
8. NYHA IV functional class
9. Participation in another study with an active treatment arm
10. Contraindication to either MRI performance or insertion of a transvenous ICD system
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04246450
Study Brief:
Protocol Section:
NCT04246450