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.
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
- Are there results?
- Not yet: the study is under way
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.
- Conditions
- Heart Valvular Disease
- 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 group | Role | What they receive |
|---|---|---|
| Valve replacement | Sham comparator | Valve replacement Receives: Procedure: Valve replacement |
| Valve repair | Experimental | Valve repair Receives: Procedure: Valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of repeat surgery
Measured: 6 months after surgery
Incidence of valve dysfunction
Measured: 6 months after surgery
Distance between petal fusion edge and septum
Measured: Day 1
Valve opening area
Measured: Day 1
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.
- First posted7 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion19 Nov 2026 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valvular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Keli Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Keli Huang, Sichuan Provincial People's Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Research Clinical Trial Protocol for Etiology-pathology and Repair Classification of Mitral and Tricuspid Valves
- ClinicalTrials.gov ID
- NCT07863531
- Acronym / sponsor ID
- 2024ZD0527203
- Conditions
- Heart Valvular Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Keli HuangUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 19 Nov 2026 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valve replacement | Sham comparator | Procedure: Valve replacementValve replacement |
| Valve repair | Experimental | Procedure: Valve repairValve repair |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valve repairValve repair | Procedure or surgery | Valve repair |
| Valve replacementValve replacement | Procedure or surgery | Valve replacement |
Primary outcome
Rate of repeat surgery
Time frame: 6 months after surgery
Incidence of valve dysfunction
Time frame: 6 months after surgery
Distance between petal fusion edge and septum
Time frame: Day 1
Valve opening area
Time frame: Day 1
Mitral valve leaflet coaptation height
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Valve repair and Valve replacement in people with Heart Valvular Disease, run by Keli Huang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of repeat surgery (time frame: 6 months after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.