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Heart Valvular DiseaseNCT07863531

Multi-center Research Clinical Trial Protocol for Etiology-pathology and Repair Classification of Mitral and Tricuspid Valves

A study testing Valve repair and Valve replacement in people with Heart Valvular Disease, run by Keli Huang.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

The choice of valve repair is very important in the treatment of cardiac valve disease, and its core is the etiology pathology analysis, which directly determines the design of repair strategy and the quality of postoperative effect. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Valvular Disease
What is being tested?
Valve repair and Valve replacement
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
No sites listed yet
Study dates
1 Nov 2026to 1 Jan 2030
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with degenerative mitral regurgitation, rheumatic mitral disease, ischemic mitral regurgitation, or primary and secondary tricuspid regurgitation;
  • Planning to undergo surgical valve repair;
  • Understand the purpose of this trial and voluntarily participate by signing the informed consent form.

Who cannot join

  • Infective endocarditis;
  • Functional valve regurgitation due to atrial fibrillation;
  • Patients with severe and irreversible major organ failure;
  • Combined severe coagulation disorders or obvious bleeding tendencies;
  • Combined malignant tumors;
  • Patients with severe immunological diseases;
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  • Pregnant or breastfeeding women, or those planning to conceive during the trial;
  • Severe mental disorders making cooperation impossible;
  • Currently participating in other clinical trials.

About this study

The choice of valve repair is very important in the treatment of cardiac valve disease, and its core is the etiology pathology analysis, which directly determines the design of repair strategy and the quality of postoperative effect. There are significant differences in anatomic structure, dysfunction and pathological characteristics of valve lesions caused by different etiologies. Therefore, accurate etiological pathological evaluation is the basis for the selection of surgical procedures. This topic focuses on degenerative, rheumatic, ischemic mitral valve disease and primary and secondary tricuspid valve disease. Around the common bottleneck problems of unclear repair scope of plastic surgery, high conversion valve rate, and high heterogeneity of clinical operation, Delphi method is used to demonstrate the implementation experience and key points of etiology pathology surgery correlation classification; Guided by the principle of restoring the physiological matching between the valve annulus and the valve leaflet as much as possible, and based on the implementation of the scientific prism framework, the technologies such as valve leaflet repair, edge to edge, artificial chordae and shaped ring implantation were combined with UCG decision-making information. With the goal of valve leaflet closure height of 5-10mm, constriction neck less than 3mm, one-time manual success rate of more than 90%, conversion valve rate of less than 2%, and reoperation rate of less than 2% within 6 months, 200 cases of multi center clinical implementation scientific research were carried out to verify the corresponding relationship between implementation experience and key points and application, establish evidence-based transplantable surgery strategies and form operation technical specifications.

Being tested
Valve repair, Valve replacement
Medical subject headings
Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Valve repairProcedure or surgery

    Valve repair

  • Valve replacementProcedure or surgery

    Valve replacement

Study groups in NCT07863531
Study groupRoleWhat they receive
Valve replacementSham comparatorValve replacement
Receives: Procedure: Valve replacement
Valve repairExperimentalValve repair
Receives: Procedure: Valve repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of repeat surgery

    Measured: 6 months after surgery

  2. Incidence of valve dysfunction

    Measured: 6 months after surgery

  3. Distance between petal fusion edge and septum

    Measured: Day 1

  4. Valve opening area

    Measured: Day 1

  5. Mitral valve leaflet coaptation height

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion19 Nov 2026 (estimated)
  4. Study completion1 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07863531
Sponsor's protocol ID
2024ZD0527203
Other IDs
2024ZD527200
Status last verified
Oct 2026
First submitted
22 Sep 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

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