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 @ 6:34 PM
Ignite Modification Date:
2025-12-24 @ 6:34 PM
NCT ID:
NCT05572957
Eligibility Criteria:
Inclusion Criteria:
1. Non-ischemic cardiomyopathy with LVEF≤35% as assessed by echocardiography, NYHA class II-III, and less than 3 months of optimized (complete) GDMT\*;
2. Sinus rhythm (paroxysmal atrial fibrillation may be present) with complete left bundle branch block meeting STRAUSS's criteria;
3. Between the ages of 18 and 80;
4. With informed consent signed.
Exclusion Criteria:
1. After mechanical tricuspid valve replacement;
2. Ischemic cardiomyopathy;
3. Persistent AF without AV node ablation;
4. History of unexplained syncope or indications for pacemaker implantation;
5. Indications for ICD implantation such as a history of sustained ventricular tachycardia or sudden cardiac arrest;
6. Unstable angina, acute MI, CABG or PCI within the past 3 months;
7. Enrollment in any other study；
8. A life expectancy of less than 12 months;
9. Pregnant or with child-bearing potential;
10. History of heart transplantation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05572957
Study Brief:
Protocol Section:
NCT05572957