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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT03614169
Eligibility Criteria:
Inclusion Criteria:
* Patients with ischaemic or non-ischaemic cardiomyopathy
* LVEF ≤ 35 % as assessed by echocardiography
* New York Heart Association (NYHA) class II-IV despite optimal medical therapy
* Either found eligible for cardiac resynchronization therapy (CRT-P or CRT-D) because of sinus rhythm and "true" LBBB according to Strauss criteria on a 12-lead ECG
* or found eligible for upgrade of an existing pacing system to cardiac resynchronization therapy (CRT-P or CRT-D) because of sinus rhythm and "true" LBBB according to Strauss criteria on a 12-lead ECG or at least 90 % right ventricular pacing in the preceding two months.
* Signed informed consent
Exclusion Criteria:
* Existing biventricular pacing system
* Permanent atrial fibrillation
* Severe kidney failure (eGFR \< 30 ml/min)
* Acute myocardial infarction or Coronary By-pass Grafting within the preceding three months
* unwillingness to participate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03614169
Study Brief:
Protocol Section:
NCT03614169