NCT06633159 MitraClip in Patients With Heart Failure
| NCT ID | NCT06633159 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The League of Clinical Research, Russia |
| Condition | Mitral Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 196 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 196 participants in total. It began in 2024-04-15 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Sergey A Boytsov, Prof.
STUDY CHAIR
Research Institute of Cardiology
Frequently Asked Questions
Who can join the NCT06633159 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06633159 currently recruiting?
Yes, NCT06633159 is actively recruiting participants. Contact the research team at melikhov.oleg@gmail.com for enrollment information.
Where is the NCT06633159 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT06633159 clinical trial?
NCT06633159 is sponsored by The League of Clinical Research, Russia. The principal investigator is Sergey A Boytsov, Prof. at Research Institute of Cardiology. The trial plans to enroll 196 participants.