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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT03420833
Eligibility Criteria:
Inclusion Criteria:
* Left Ventricular Ejection Fraction (LVEF) 35%-50%
* New York Heart Association (NYHA) class I-II
* QRS duration of ≥120ms
* Left bundle branch block (LBBB)
* Patient is able to receive a transvenous pectoral CRT implant
* Patient is able to sign informed consent
* Two echocardiograms are required to confirm a stable reduced LVEF
* Patient is on optimal and stable medical therapy (ACE inhibitor or angiotensin II type 1 (AT1 )blocker, beta blocker, etc. over the last 6 months)
Exclusion Criteria:
* Advanced comorbid conditions with life expectancy \<1 year
* Patient is \<18 of years of age
* Patient has a CRT device
* Female patients who is pregnant or not on a reliable form of birth control. Women of childbearing potential are required to have negative pregnancy test within the 7 days prior to device implant
* Unwilling or unable to return for required follow-up visits
* Patient decides study participation is cost-prohibited
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03420833
Study Brief:
Protocol Section:
NCT03420833