Functional Mitral Regurgitation (FMR)
Conditions
Interventions
Experimental group:Transcatheter mitral annular intervention repair
Control group:Guideline Directed Medical Therapy,GDMT
Sponsors
Fuwai Hospital, CAMS & PUMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Echocardiography confirms moderate-to-severe (3+) or severe (4+) functional mitral regurgitation; 3. Patients with a history of hospitalization for heart failure within the past six months, who still exhibit clinical symptoms of heart failure (HF) after one month of treatment with the maximum dosage of guideline-directed medical therapy (GDMT) (including CRT therapy, if necessary), and have a New York Heart Association (NYHA) functional classification of II-IV; 4. The heart team at the local clinical trial institution has assessed the patient as high-risk for surgical intervention, making surgery unsuitable. The patient can only rely on medication; 5. After the researchers evaluated the anatomical structure of the mitral valve as suitable, the experimental device can be used for mitral annuloplasty; 6. The subjects or their guardians are able to understand the purpose of the trial, voluntarily participate and sign a written informed consent form, and are able to undergo follow-up visits as required by the protocol.
Exclusion criteria
Exclusion criteria: 1. Left ventricular ejection fraction (LVEF) 70% as shown by ultrasound examination) or having undergone carotid surgery or stent implantation within 1 month; 15. History of acute peptic ulcer or gastrointestinal bleeding within 3 months; 16. There are contraindications to transesophageal echocardiography or general anesthesia; 17. Atrial septal defect or previous repair of atrial septal defect; 18. Suffering from hemorrhagic diseases or coagulation disorders; or having contraindications to antithrombotic drug therapy; 19. Subjects with end-stage heart failure (ACC/AHAD stage), or after heart transplantation, or waiting for heart transplantation; 20. Subjects with life expectancy less than 1 year; 21. Subjects who are pregnant, breastfeeding, or planning to give birth within the next year; 22. Participating in other clinical trials and not yet reaching the trial endpoint; 23. Other conditions that the researchers consider unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective treatment rate at 6 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical Success Rate;Device Success Rate;Quality of Life Improvement; | — |
Countries
China
Contacts
Public ContactPan Xiangbin
Fuwai Hospital, CAMS & PUMC
Outcome results
None listed