MitraClip in Patients With Heart Failure

Launched by THE LEAGUE OF CLINICAL RESEARCH, RUSSIA · Oct 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a device called the MitraClip in patients with a heart condition known as mitral regurgitation, where the heart's mitral valve doesn’t close tightly, causing blood to flow backward into the heart. The trial is observational, meaning that it will observe patients as they receive standard treatment without changing how doctors usually care for them. It aims to include at least 196 patients across 11 clinics in Russia, focusing on those who are undergoing a specific type of heart surgery to correct this condition using the MitraClip.

To be eligible for the trial, participants must be at least 18 years old and have been recommended for surgery to fix their mitral regurgitation with the MitraClip. Patients who have serious other health problems, those with a life expectancy of less than a year, or those unable to follow the study’s requirements may not qualify. Participants can expect to share their medical information, and their progress will be monitored, helping researchers gather valuable insights about the MitraClip's effectiveness in real-world settings. This study is important as it aims to enhance understanding and treatment of heart conditions in patients.

Gender

ALL

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.