MitraClip in Patients With Heart Failure (MitraClip)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: MitraClip

Detailed Description

Mitral regurgitation (MR) may result from either degenerative lesions of the mitral valve (MV) leaflets - degenerative MR (DMR) - or pathological dilation of the left ventricle (LV) - functional MR (FMR). In DMR, the MV apparatus itself is compromised by affected leaflets, chords, etc. In contrast, FMR is usually associated with cardiomyopathy (usually of ischemic etiology), with this type of MR being secondary to LV dysfunction. In both cases, there is a violation of leaflet co-optation and reverse blood flow from the LV into the left atrium. According to existing guidelines, surgical reconstruction (plastic surgery) is the preferred treatment option for DMR. Indications for invasive treatment of FMR are not so clear-cut due to the high rate of postoperative MR recurrence and the lack of reliable evidence of a positive effect of FMR correction on long-term survival. The greatest complexity is presented by the group of patients with severe MR and high or unacceptable surgical risk of open surgery.

For the treatment of severe MR in such patients, the method of transcatheter MV repair was proposed, which is an endovascular analogue of the suture "edge-to-edge" repair according to Alfieri. MitraClip system is approved in the European Union, the USA, the Middle East and the CIS (Kazakhstan, Belarus) for the treatment of high surgical risk patients with DMR and FMR with symptomatic heart failure of II-IV functional class according to the classification of the New York Heart Association (NYHA), persisting despite optimal drug therapy.

The aim of this study is to evaluate the safety and effectiveness of the procedure of percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets in a population of patients from the Russian Federation for the treatment of mitral regurgitation. Information on the health status of patients who have undergone the procedure of percutaneous transcatheter edge-to-edge mitral valve reconstruction by implanting the MitraClip clip on the mitral valve leaflets will be of high scientific and practical interest.

• Study Type: Observational
• Enrollment (Estimated): 196

Contacts and Locations

• Study Contact: Name: Oleg Melikhov, MD; Phone Number: +79166950530; Email: melikhov.oleg@gmail.com
• Study Contact Backup: Name: Svetlana Elkonina; Phone Number: +79164454877; Email: elkonina.svetlana@gmail.com

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119590
    • Recruiting
    • League of Clinical Research (LeagueCRR)
    • Contact: Oleg G Melikhov, MD, PhD; Phone Number: 0079166950530; Email: melikhov.oleg@gmail.com
    • Contact: Svetlana I Elkonina, MD; Phone Number: 0079164454877; Email: elkonina.svetlana@gmail.com
    • Principal Investigator: Sergei A Boytsov, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; surgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets
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; surgical intervention to correct mitral regurgitation by percutaneous transcatheter implantation of the MitraClip G4 clip on the mitral valve leaflets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	To assess all-cause mortality within 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.	Month 12
Hospitalization for heart failure	To assess the incidence of hospitalization for heart failure within 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.	Month 12
Hospitalization for any cause	To assess the incidence of hospitalization for any cause within 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.	Month 12
Emergency surgical interventions	To assess the frequency of unplanned (emergency) surgical interventions on the mitral valve within 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.	Month 12
Functional class of heart failure	To assess the change in the functional class of heart failure within 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.	Month 1 - Month 3 - Month 12
N-terminal pre-brain natriuretic peptide	To assess the change in the level of N-terminal pre-brain natriuretic peptide over 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.	Month 1 - Month 12
Echocardiographic examination: severity of mitral regurgitation: I-IV;	To evaluate the change in echocardiographic examination parameters within 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.	Month 1 - Month 12
Echocardiographic examination:presence of severe mitral valve stenosis ;	To evaluate the change in echocardiographic examination parameters: presence of severe mitral valve stenosis within 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.	Month 1 - Month 12
Surgical complications	To assess the incidence of surgical complications within 12 months after correction of mitral regurgitation by percutaneous transcatheter implantation of the MitraClip on the mitral valve leaflets.	Month 12
Safety of surgical intervention	Surgical complications after correction of mitral regurgitation: yes/no. If yes: date of development of the complication, description of the complication (ICD-10 term), outcome of the complication at the 12-month follow-up period (death, resolved without consequences, resolved with consequences, ongoing).	Month 12
Safety of surgical intervention:AE	Adverse events: yes/no If yes: date of development of the AE, description of the AE (ICD-10 term), outcome of the AE by the 12-month follow-up period (death, resolved without consequences, resolved with consequences, ongoing).	Month 12
Safety of surgical intervention: сardiac surgery	Cardiac surgery during the 12-month follow-up period	Month 12

Collaborators and Investigators

• Sponsor: The League of Clinical Research, Russia
• Collaborators: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
• Investigators: Study Chair: Sergey A Boytsov, Prof., Research Institute of Cardiology

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Estimated): October 9, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: MitraClip; Clip implantation; Transcatheter plastic surgery; Mitral valve (MV); Mitral regurgitation (MR)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Heart Failure; Mitral Valve Insufficiency
• Other Study ID Numbers: СН-01-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No