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 @ 10:16 PM
Ignite Modification Date:
2025-12-24 @ 10:16 PM
NCT ID:
NCT00746135
Eligibility Criteria:
Inclusion Criteria:
* Patient with indication for CRT-D: NYHA III-IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure
* LVEDD \> 55 mm or \> 30 mm/m² BSA
* EF \< 35%
* Sinus rhythm and one of the following criteria:
* QRS \>= 120 ms and PQ \>= 200ms
* or
* 2nd / 3rd degree AV block
* Written informed consent
Exclusion Criteria:
* pacemaker indication (without ICD indication)
* tricuspidal valve and/or aortic valve replacement
* Indication for revascularization.
* less than 3 month after heart surgery or myocardial infarction
* hypertrophic obstructive cardiomyopathy
* intravenous catecholamine treatment
* uncorrected thyroid function
* severe kidney disorder (creatinin \>2,5mg%)
* no written patient consent
* insufficient patient compliance
* participating in another study
* life expectancy \< 1 year due to other severe disease
* age \< 18 years
* no contraception (young women) or pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00746135
Study Brief:
Protocol Section:
NCT00746135