MitraClip in Patients With Heart Failure

NCT06633159 | Recruiting FDA Device

• 1 other identifier: СН-01-2023
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

Multicenter observational study. The study does not involve any interventions in routine clinical practice, the choice of treatment method (including the type of medical device used and the method of surgical intervention) and the methods of examination and postoperative management of patients will not differ from the standard of care for patients requiring percutaneous transcatheter edge-to-edge mitral valve reconstruction by implantation of the MitraClip clip on the mitral valve leaflets, used in the daily medical practice of a medical institution. All medical devices under study (delivery device with the MitraClip clip on the mitral valve leaflets) are registered in the territory of the Russian Federation and are used in the conditions of routine medical practice. The study will include patients who have undergone surgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets. It is expected to include at least 196 patients (at least 98 prospective patients and at least 98 retrospective patients). The planned number of research centers is 11 outpatient clinics, presumably in 6 regions of the Russian Federation.

Conditions

Mitral Regurgitation

Keywords

Clip implantation; Transcatheter plastic surgery; Mitral valve (MV); MitraClip; Mitral regurgitation (MR)

Outcome Measures

Primary Outcomes (1)

• Cardiovascular mortality

  To evaluate cardiovascular mortality within 12 months in patients with heart failure after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.

  Month 12

Secondary Outcomes (12)

• All-cause mortality

  Month 12

• Hospitalization for heart failure

  Month 12

• Hospitalization for any cause

  Month 12

• Emergency surgical interventions

  Month 12

• Functional class of heart failure

  Month 1 - Month 3 - Month 12

Study Arms (2)

prospective

The prospective part of the study will include patients who have undergone hospitalization for the purpose of surgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets.

Device: MitraClip

retrospective

The retrospective part of the study will include patients who underwent surgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets.

Device: MitraClip

Interventions

MitraClip DEVICE

surgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets

prospective; retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 years and older with heart failure and implanted MitraClip G4 mitral valve clips.

You may qualify if:

• 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.
• Age 18 years and older.
• Understanding and voluntarily signing the informed consent form for the processing of personal data.

You may not qualify if:

• The expected life expectancy of the patient is less than 12 months (contraindication to surgical intervention).
• The presence of concomitant diseases that limit the patient's ability to carry out visits according to the study protocol.
• Conditions that limit the patient's ability to comply with the study requirements (dementia, psychoneurological diseases, drug addiction, alcoholism, etc.).
• Simultaneous participation in other clinical trials or previous participation in this trial.
• Cohort 2 (retrospective patients)
• 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.
• 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.
• The surgery must have been performed no earlier than January 1, 2022.
• Age 18 years and older.

Sponsors & Collaborators

• The League of Clinical Research, Russia: lead
• National Medical Research Center for Cardiology, Ministry of Health of Russian Federation: collaborator

Study Sites (1)

League of Clinical Research (LeagueCRR)

Moscow, 119590, Russia

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Sergey A Boytsov, Prof.

  Research Institute of Cardiology

  STUDY CHAIR

Central Study Contacts

Oleg Melikhov, MD

CONTACT

+79166950530; melikhov.oleg@gmail.com

Svetlana Elkonina

CONTACT

+79164454877; elkonina.svetlana@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 9, 2024
• Study Start: April 15, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)