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 @ 5:46 PM
Ignite Modification Date:
2025-12-24 @ 5:46 PM
NCT ID:
NCT05677568
Eligibility Criteria:
Inclusion Criteria:
1. Patients with functional mitral regurgitation (i.e., dilated cardiomyopathy), in accordance with CE-mark approved labeling
2. Patients implanted with the Carillon device
3. Patients must be ≥ 18 years old
4. Patients require informed consent prior to inclusion in this registry
5. Minimum baseline data, as described in CINCH Protocol, including:
* Hemodynamic measures (by echocardiography)
* Baseline must include the following measurements: MR grade, LVEF (%), LVEDD, LAD, and AP \& ML diameters
* NYHA Classification
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05677568
Study Brief:
Protocol Section:
NCT05677568