Mitral regurgitation
Conditions
Interventions
Two groups:cardiac valvuloplasty ring: Permed Company, Beijing versus Edward Co., Shanghai
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Patients with mitral valve degeneration, rheumatic valve disease and other reasons that cause mitral valve disease and meet the indications for mitral valve surgical repair; 3. NYHA heart function below grade III (including grade III) before surgery; 4. The patient or his guardian learns of the nature of the trial and agrees to all terms of participation in the trial, voluntarily sign an informed consent form approved by the ethics committee, agree to accept the postoperative treatment plan and follow-up requirements, and be able to complete the follow-up and follow-up inspections.
Exclusion criteria
Exclusion criteria: 1. Patients who are contraindicated for mitral valvuloplasty ring implantation or have received mitral valve surgery in the past; 2. Heart failure patients with heart function grade IV; 3. Patients with left atrium or left ventricular thrombosis determined by the investigator to increase the risk of surgery; 4. Patients undergoing heart transplantation; 5. Patients undergoing emergency surgery; 6. Patients whose expected survival time is less than 1 year; 7. Received cardiac surgery or interventional surgery or had a cerebrovascular event 3 months before the operation; 8. Renal failure requires renal dialysis treatment; 9. Severe respiratory disorder; 10. Active infectious endocarditis; 11. Active infection, sepsis, bacteremia or unexplained fever; 12. Bleeding diseases such as active peptic ulcer or gastrointestinal bleeding, or hypercoagulable state; 13. Patients with contraindications to the use of anticoagulant and antiplatelet drugs; 14. Patients who are known to have a history of allergies to metal nickel-titanium alloys, silicone materials, and polyester materials; 15. Pregnant or lactating women; 16. The subject is or will be participating in the research of another device or drug; 17. Patients judged by the investigator to be unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of repair; | — |
Contacts
Public ContactWang Dongjin
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed