Using MitraClip to treat heart failure caused by mitral regurgitation

Register of Patients With Heart Failure Who Underwent Surgery to Correct Mitral Regurgitation by Percutaneous Catheter Implantation of MitraClip on the Mitral Valve.

This study looks at how well the MitraClip device works for people with heart failure caused by a leaky mitral valve who are at high risk for surgery.

Quick facts

• Study type: Observational
• Enrollment: 196 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The League of Clinical Research, Russia (Academic / other)
• Locations: 1 site (Moscow)
• Trial ID: NCT06633159 on ClinicalTrials.gov

What this trial studies

This multicenter observational study examines patients with mitral regurgitation who are undergoing treatment with the MitraClip device, a minimally invasive procedure for mitral valve repair. The study does not involve any experimental interventions; instead, it observes standard clinical practices for patients receiving the MitraClip. It aims to gather data on the outcomes of patients with degenerative and functional mitral regurgitation who are at high surgical risk. The study includes both prospective and retrospective cohorts to evaluate the effectiveness of the MitraClip in routine clinical settings.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are indicated for cardiac surgery to correct mitral regurgitation using the MitraClip.

Not a fit: Patients with a life expectancy of less than 12 months or those with conditions that limit their ability to comply with study requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of MitraClip for patients with severe mitral regurgitation, potentially improving treatment options for heart failure.

How similar studies have performed: Other studies have shown success with similar approaches using the MitraClip for treating mitral regurgitation, indicating a promising avenue for patient care.

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.

Where this trial is running

Moscow

• League of Clinical Research (LeagueCRR) — Moscow, Russia (Recruiting)

Study contacts

• Study coordinator: Oleg Melikhov, MD

Conditions Mitral Regurgitation; Clip implantation; Transcatheter plastic surgery; Mitral valve; MitraClip; Mitral regurgitation