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:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT05265520
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older (no upper age limit)
* Optimal medical therapy for heart failure by current guidelines
* Class IIa or IIb guideline-based indication for CRT-D implant in RBBB patients, including one of the following:
* New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb); OR
* NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa); OR
* NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration 120-149 ms (IIb)
Exclusion Criteria:
* Unable to obtain most recent imaging data from echocardiogram within 1 year prior to date of randomization
* Left bundle branch block (LBBB) or intraventricular conduction delay (IVCD) ECG morphology
* Unable or unwilling to follow study protocol
* Less than 12 months life expectancy at consent
* Pregnancy or planned pregnancy during duration of the study
* On heart transplant list or likely to undergo heart transplant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05265520
Study Brief:
Protocol Section:
NCT05265520