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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT00399594
Eligibility Criteria:
Inclusion Criteria:
* LV EF ≤ 0.40 measured within 3 months of enrollment,
* SAS class 3 or 4 symptoms indicative of moderate to severe functional capacity limitation due to heart failure within 1 month of enrollment.
* Confirmed dyssynchrony on screening echo (1.1.9), \&
* On stable doses of ACE inhibitor or angiotensin II blocker \& a beta-blocker for ≥ 2 months unless medically contra-indicated.
* Controlled heart rate if in permanent AF (resting \<70 \& maximal \<120).
Exclusion Criteria:
* Unable or unwilling to provide informed consent,
* Medical condition other than heart failure likely to cause death \< 1 year,
* Cardiac transplant planned within 6 months,
* Known contra-indication to transvenous CRT device implant (e.g., active sepsis, artificial tricuspid valve, known vascular occlusion that will prevent delivery of leads transvenously),
* Clinically significant myocardial infarction within last 2 months, or
* Coronary bypass graft surgery ≤ 2 months or coronary angioplasty ≤ 1 month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00399594
Study Brief:
Protocol Section:
NCT00399594