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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT01615835
Eligibility Criteria:
Inclusion Criteria:
* Meet criteria for CRT implant including EF\<35%, QRS\>120ms, NYHA class III or IV
* Persistent CHF symptoms despite optimization
* Stable/optimal medical therapy
* History of ischemic or non-ischemic cardiomyopathy
Exclusion Criteria:
* Any standard device exclusion including TVR
* Positive pregnancy test
* Currently participating in IDE/IND study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01615835
Study Brief:
Protocol Section:
NCT01615835