Mitral Regurgitation (MR)NCT07284212
A Prospective Multicenter Cohort Study on Surgical Treatment Strategies for Pediatric Mitral Regurgitation
An observational study of Mitral Regurgitation (MR) and Pediatric Cardiac Surgery, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This prospective, multicenter cohort study aims to evaluate the outcomes of surgical repair for pediatric mitral regurgitation (MR) in China. From March 2020 to December 2024, consecutive patients younger than 14 years who underwent mitral valve repair at eight representative congenital heart disease centers were… Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Mitral Regurgitation (MR), Pediatric Cardiac Surgery
- What is being tested?
- conventional mitral valve repair and standardized mitral valve repair
- Type of treatment
- Surgery or procedure
- How many people
- 427 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2020to 20 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children younger than 14 years with moderate or greater mitral regurgitation undergoing surgical repair at eight representative congenital heart disease centers in China. Eligible patients must not have undergone prior mitral valve surgery and must meet the predefined inclusion and exclusion criteria. The study aims to prospectively evaluate surgical outcomes, durability, and predictors of repair from March 2020 to December 2024, with follow-up completed through September 2025.
Who may be able to join
- Age < 14 years
- No prior mitral valve surgery
- Preoperative echocardiography demonstrating moderate or severe mitral regurgitation
Who cannot join
- Concomitant cardiac malformations unable to be corrected simultaneously
- Moderate or severe mitral stenosis
- Ischemic mitral regurgitation
- Severe leaflet dysplasia precluding adequate coaptation
- Connective tissue disorders(e.g., Barlow's disease, Marfan syndrome)
- Any type of cardiomyopathy
- Single ventricle physiology or common atrioventricular valve
Trial locations and contacts
1 site in 1 country.
China1 site
Pediatric Cardiac Surgery Center, Fuwai Hospital
Beijing, Beijing Municipality, 100037
About this study
This prospective, multicenter cohort study aims to evaluate the outcomes of surgical repair for pediatric mitral regurgitation (MR) in China. From March 2020 to December 2024, consecutive patients younger than 14 years who underwent mitral valve repair at eight representative congenital heart disease centers were enrolled. Eligible patients were those with at least moderate MR on preoperative echocardiography and no prior mitral valve surgery. Patients with uncorrectable concomitant cardiac anomalies, moderate or greater mitral stenosis, ischemic MR, severe leaflet dysplasia, connective tissue disorders (e.g., Barlow, Marfan), cardiomyopathies, or single-ventricle physiology were excluded.
The primary endpoint is a composite of all-cause mortality, reoperation for cardiovascular causes, or recurrence of moderate-or-severe MR during follow-up. Secondary endpoints include perioperative outcomes such as postoperative hospital stay, intensive care unit stay, mechanical ventilation time, and hospitalization cost.
This study is designed to provide high-quality prospective evidence on the safety, durability, and predictors of surgical repair for pediatric MR in a contemporary, real-world, multicenter setting. The findings may inform surgical decision-making and postoperative management strategies for this rare but challenging population.
- Being tested
- conventional mitral valve repair, standardized mitral valve repair
- Keywords
- Mitral Regurgitation, Pediatric Cardiac Surgery, Mitral Valve Repair, Surgical Outcomes
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional mitral valve repairProcedure or surgery
Patients undergoing conventional mitral valve repair, including annuloplasty, leaflet cleft closure, chordal transfer, and chordal resection, et al.
standardized mitral valve repairProcedure or surgery
Patients undergoing the standardized mitral valve repair strategy proposed by Professor Li at Fuwai Hospital in 2016, which involves comprehensive exploration and correction of abnormalities at the subvalvular, leaflet, and annular levels.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Group | Those who have undergone conventional mitral valve repair Receives: Procedure: conventional mitral valve repair | |
| Standardized Group | Those who have undergone standardized mitral valve repair Receives: Procedure: standardized mitral valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Primary Endpoint
Time-to-first event of any of the following: (a) all-cause mortality; (b) mitral valve reoperation; or (c) recurrence of ≥ moderate mitral regurgitation on transthoracic echocardiography.
Measured: From date of index surgery until last follow-up (up to 5 years)
Secondary outcomes (4)
Postoperative Hospital Length of Stay
Total postoperative days from surgery to hospital discharge.
Measured: perioperatively
ICU Length of Stay
Consecutive time in intensive care unit.
Measured: perioperatively
Duration of Invasive Mechanical Ventilation
Cumulative duration of invasive mechanical ventilation during the index hospitalization, including all episodes of intubation and re-intubation.
Measured: perioperatively
Hospitalization Cost
Total in-hospital medical cost for the index surgical admission (local currency), extracted from billing records.
Measured: perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start18 Mar 2020
- Primary completion20 Sep 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Regurgitation (MR)Studies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284212
- Sponsor's protocol ID
- 2020-FW-MR
- Status last verified
- Dec 2025
- First submitted
- 24 Sep 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data underlying this article cannot be shared publicly for the privacy of individuals that participated in the study.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Cohort Study on Surgical Treatment Strategies for Pediatric Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT07284212
- Acronym / sponsor ID
- 2020-FW-MR
- Keywords
- Mitral Regurgitation, Pediatric Cardiac Surgery, Mitral Valve Repair, Surgical Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 16 Dec 2025 (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.
This prospective, multicenter cohort study aims to evaluate the outcomes of surgical repair for pediatric mitral regurgitation (MR) in China. From March 2020 to December 2024, consecutive patients younger than 14 years who underwent mitral valve repair at eight representative congenital heart disease centers were enrolled. Eligible patients were those with at least moderate MR on preoperative echocardiography and no prior mitral valve surgery. Patients with uncorrectable concomitant cardiac anomalies, moderate or greater mitral stenosis, ischemic MR, severe leaflet dysplasia, connective tissue disorders (e.g., Barlow, Marfan), cardiomyopathies, or single-ventricle physiology were excluded.
The primary endpoint is a composite of all-cause mortality, reoperation for cardiovascular causes, or recurrence of moderate-or-severe MR during follow-up. Secondary endpoints include perioperative outcomes such as postoperative hospital stay, intensive care unit stay, mechanical ventilation time, and hospitalization cost.
This study is designed to provide high-quality prospective evidence on the safety, durability, and predictors of surgical repair for pediatric MR in a contemporary, real-world, multicenter setting. The findings may inform surgical decision-making and postoperative management strategies for this rare but challenging population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Group | – | Procedure: conventional mitral valve repairThose who have undergone conventional mitral valve repair |
| Standardized Group | – | Procedure: standardized mitral valve repairThose who have undergone standardized mitral valve repair |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children younger than 14 years with moderate or greater mitral regurgitation undergoing surgical repair at eight representative congenital heart disease centers in China. Eligible patients must not have undergone prior mitral valve surgery and must meet the predefined inclusion and exclusion criteria. The study aims to prospectively evaluate surgical outcomes, durability, and predictors of repair from March 2020 to December 2024, with follow-up completed through September 2025.
Key inclusion criteria (3 listed)
- Age < 14 years
- No prior mitral valve surgery
- Preoperative echocardiography demonstrating moderate or severe mitral regurgitation
Key exclusion criteria (7 listed)
- Concomitant cardiac malformations unable to be corrected simultaneously
- Moderate or severe mitral stenosis
- Ischemic mitral regurgitation
- Severe leaflet dysplasia precluding adequate coaptation
- Connective tissue disorders(e.g., Barlow's disease, Marfan syndrome)
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 |
|---|---|---|
| conventional mitral valve repairPatients undergoing conventional mitral valve repair, including annuloplasty, leaflet cleft closure, chordal transfer, and chordal resection, et al. | Procedure or surgery | Conventional Group |
| standardized mitral valve repairPatients undergoing the standardized mitral valve repair strategy proposed by Professor Li at Fuwai Hospital in 2016, which involves comprehensive exploration and correction of abnormalities at the subvalvular, leaflet, and annular levels. | Procedure or surgery | Standardized Group |
Primary outcome
Composite Primary Endpoint
Time frame: From date of index surgery until last follow-up (up to 5 years)
Time-to-first event of any of the following: (a) all-cause mortality; (b) mitral valve reoperation; or (c) recurrence of ≥ moderate mitral regurgitation on transthoracic echocardiography.
4 secondary outcomes
Postoperative Hospital Length of Stay
Time frame: perioperatively
ICU Length of Stay
Time frame: perioperatively
Duration of Invasive Mechanical Ventilation
Time frame: perioperatively
Hospitalization Cost
Time frame: perioperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No. The data underlying this article cannot be shared publicly for the privacy of individuals that participated in the study.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation (MR) and Pediatric Cardiac Surgery, run by China National Center for Cardiovascular Diseases at 1 site in China.
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 7 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: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite Primary Endpoint (time frame: From date of index surgery until last follow-up (up to 5 years)). 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 16 Dec 2025.