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A prospective, multi-center, randomized controlled clinical trial to evaluate the safety and effectiveness of cardiac valvuloplasty ring for the treatment of tricuspid regurgitation

A prospective, multi-center, randomized controlled clinical trial to evaluate the safety and effectiveness of cardiac valvuloplasty ring for the treatment of tricuspid regurgitation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043007
Enrollment
Unknown
Registered
2021-02-04
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tricuspid regurgitation

Interventions

Test:Permed mitral ring

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age =18 years old and =75 years old; 2. Patients with tricuspid valve disease caused by tricuspid valve degeneration, functional valve disease, etc., and who meet the indications for tricuspid valve surgery; 3. NYHA heart function below grade III (including grade III) before surgery; 4. The patient or his guardian learns of the nature of this trial and agrees to all the terms of participating in this 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 required inspections;

Exclusion criteria

Exclusion criteria: 1. Patients who are contraindicated for tricuspid valvuloplasty ring implantation or have previously received tricuspid valve surgery; 2. Heart failure patients with heart function grade IV, patients with right heart failure; 3. Patients whose right atrium or right ventricular thrombosis is judged 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 anticoagulants 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

MeasureTime frame
Success rate of repair;

Countries

China

Contacts

Public ContactWang Dongjin

Nanjing Drum Tower Hospital

dongjinwang_gl@163.com+86 13915980346

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026