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 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
NCT ID:
NCT06633159
Eligibility Criteria:
Cohort 1 (prospective patients)
Inclusion Criteria:
1. Patients who are indicated for cardiac surgery to correct mitral regurgitation using transcatheter edge-to-edge reconstruction of the mitral valve by implanting the MitraClip G4 on the cusps of the mitral valve.
2. Age 18 years and older.
3. Understanding and voluntarily signing the informed consent form for the processing of personal data.
Exclusion Criteria:
1. The expected life expectancy of the patient is less than 12 months (contraindication to surgical intervention).
2. The presence of concomitant diseases that limit the patient's ability to carry out visits according to the study protocol.
3. Conditions that limit the patient's ability to comply with the study requirements (dementia, psychoneurological diseases, drug addiction, alcoholism, etc.).
4. Simultaneous participation in other clinical trials or previous participation in this trial.
Cohort 2 (retrospective patients)
Inclusion Criteria:
1.Patients who underwent cardiac surgery to correct mitral regurgitation using transcatheter edge-to-edge mitral valve reconstruction with MitraClip G4 clip implantation on the mitral valve leaflets.
Exclusion Criteria:
1. Patients for whom the physician-researcher cannot access primary medical documentation (medical records, outpatient cards) to collect complete and reliable information about the patient in the volume required by the study protocol.
2. The surgery must have been performed no earlier than January 1, 2022.
3. Age 18 years and older.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06633159
Study Brief:
Protocol Section:
NCT06633159