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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT00538356
Eligibility Criteria:
Inclusion Criteria:
* Indication for single chamber ICD, dual chamber ICD or CRT-D
* Chronic heart failure (≥ 3 months)
* NYHA Class II or III for 1 month prior to screening
* LVEF ≤ 35% within 3 months prior to screening
* Indication for therapy with diuretics
* Patient informed consent
Exclusion Criteria:
* Uncontrolled hypertension
* NYHA class I or IV
* Permanent atrial fibrillation
* Life expectancy \< 1 year
* Restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, acute myocarditis
* Severe mitral regurgitation
* Symptomatic aortic stenosis
* Tricuspid valve replacement
* Known drug or alcohol abuse
* Expected non-compliance
* Pregnancy
* Participation in another telemonitoring concept
* Participation in another study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00538356
Study Brief:
Protocol Section:
NCT00538356