Congenital Mitral InsufficiencyNCT06037447
Study of Innovative Strategies for Mitral Valve Repair
An observational study of Congenital Mitral Insufficiency, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
The goal of this observational study is to compare the safety and effectiveness of a 3-steps standardized repair-oriented strategy with annuloplasty only in pediatric patients with mild to moderate mitral valve regurgitation. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Congenital Mitral Insufficiency
- What is being tested?
- 3-steps standardized repair-oriented strategy
- Type of treatment
- Surgery or procedure
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 31 Dec 2024
- How long will I take part?
- 6 Months
- 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 under the age of 14 with moderate to severe mitral valve regurgitation
Who may be able to join
- < 14 years old
- had not undertake mitral valve surgery before
- moderate to severe mitral regurgitation
Who cannot join
- moderate to severe mitral regurgitation which concommitant with other cardiac malformation which can not be correct or can only perform palliative surgery
- concommitant with mitral stenosis
- ischemic mitral regurgitation (for example, concommitant with anomalous origin of coronary artery)
- Barlow syndrome
- dysplasia of mitral leaflet
- complete/Partial endocardial cushion defect
Show all 10Show fewer
- common atrioventricular valve
- atrioventricular common channel
- cardiomyopathy
- other mitral valve surgery contraindications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai hospital
Beijing, Beijing Municipality, 100037
Shoujun Li, MD, +86 13501071589, drlishoujunfw@163.com
About this study
Official title: A Prospective Controlled Study for the Treatment Effect of Different Intervention Strategies for Pediatric Mitral Regurgitation--A Multicenter Prospective Cohort Study of Innovative Strategies for Mitral Valve Repair
The goal of this observational study is to compare the safety and effectiveness of a 3-steps standardized repair-oriented strategy with annuloplasty only in pediatric patients with mild to moderate mitral valve regurgitation.
The main questions it aims to answer are:
Read more
- Can 3-steps standardized repair-oriented strategy improve both left ventricular and mitral valve function in pediatric patients with mild to moderate mitral valve regurgitation?
- Can surgical complications caused by the 3-steps standardized repair-oriented strategy be non-inferior (clinically acceptable) to annuloplasty only? Participants will be assigned to either the Standardized Group (including subvalvular apparatus rehabilitation (leaflet plication if chordae absent on leaflet margin, mal-connected chordae resection if chordae mal-connected to leaflet body, papillary muscle splitting if short chordae or dysplastic or fused papillary muscle etc.), leaflets repair (leaflets plication if functional leaflet prolapse, leaflet cleft closure and patch augmentation for anatomical leaflet defect, etc.) and annuloplasty (posterior annuloplasty for annular dilatation and shallow leaflet coaptation, etc.)) or the Annuloplasty Group (annuloplasty only during mitral repair surgeries. Additionally, echocardiography, electrocardiograms, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of surgery and at 1 months, 3 months, and 6 months after mitral repair.
Researchers will compare the Standardized Group and the Annuloplasty Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 6 months of surgery, is lower in the former than in the latter.
- Conditions
- Congenital Mitral Insufficiency
- Being tested
- 3-steps standardized repair-oriented strategy
- Keywords
- congenital heart disease, mitral regurgitation, mitral valve repair
- Medical subject headings
- Heart Defects, Congenital, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-steps standardized repair-oriented strategyProcedure or surgery
3-steps standardized repair-oriented strategy, including subvalvular apparatus rehabilitation (leaflet plication if chordae absent on leaflet margin, mal-connected chordae resection if chordae mal-connected to leaflet body, papillary muscle splitting if short chordae or dysplastic or fused papillary muscle etc.), leaflets repair (leaflets plication if functional leaflet prolapse, leaflet cleft closure and patch augmentation for anatomical leaflet defect, etc.) and annuloplasty (posterior annuloplasty for annular dilatation and shallow leaflet coaptation, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Standardized Group | Patients in this group will undergo standardized strategy during mitral repair surgeries, including subvalvular apparatus rehabilitation, leaflets repair and annuloplasty. Receives: Procedure: 3-steps standardized repair-oriented strategy | |
| Annuloplasty Group | Patients in this group will undergo annuloplasty only during mitral repair surgeries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the recurrence rate of moderate to severe mitral valve regurgitation
During follow-up visits, echocardiographic examination is conducted to measure the degree of mitral valve regurgitation. If it falls within the moderate to severe range, it is recorded as a recurrence.
Measured: after 6 months of surgery
Secondary outcomes (5)
Improvement in symptoms
Based on patient and caregiver descriptions, if symptoms such as chest discomfort, shortness of breath, and delayed development show improvement following physical activity, it is recorded as an improvement in symptoms.
Measured: after 6 months of surgery
Change in left ventricular function
Based on the echocardiogram, measurements are taken for left ventricular ejection fraction.
Measured: after 6 months of surgery
Change in left ventricular function
Based on the echocardiogram, measurements are taken for left ventricular end-diastolic diameter.
Measured: after 6 months of surgery
NT-proBNP level
The trend in NT-proBNP levels.
Measured: after 6 months of surgery
Incidence rate of surgical complications
Incidence rate of surgical complications, including infection, low cardiac output, arrhythmia, cardiac insufficiency, delayed sternal closure, thromboembolism and bleeding events, neurological complications(stroke, seizures and intracerebral hemorrhage).
Measured: after 6 months of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Apr 2022
- Primary completion5 Apr 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Mitral InsufficiencyStudies 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
- 256 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Shanghai Children's Medical Center, Chinese Academy of Medical Sciences, Fuwai Hospital, Guangzhou Women and Children's Medical Center, Children's Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Shoujun Li, China National Center for Cardiovascular Diseases
- Investigators
- Shoujun Li, MD, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037447
- Sponsor's protocol ID
- 2022-GSP-GG-19-2
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Controlled Study for the Treatment Effect of Different Intervention Strategies for Pediatric Mitral Regurgitation--A Multicenter Prospective Cohort Study of Innovative Strategies for Mitral Valve Repair
- ClinicalTrials.gov ID
- NCT06037447
- Acronym / sponsor ID
- 2022-GSP-GG-19-2
- Conditions
- Congenital Mitral Insufficiency
- Keywords
- congenital heart disease, mitral regurgitation, mitral valve repair
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Shanghai Children's Medical Center, Chinese Academy of Medical Sciences, Fuwai Hospital, Guangzhou Women and Children's Medical Center, Children's Hospital of Chongqing Medical University
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 5 Apr 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Sep 2023 (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 goal of this observational study is to compare the safety and effectiveness of a 3-steps standardized repair-oriented strategy with annuloplasty only in pediatric patients with mild to moderate mitral valve regurgitation.
The main questions it aims to answer are:
- Can 3-steps standardized repair-oriented strategy improve both left ventricular and mitral valve function in pediatric patients with mild to moderate mitral valve regurgitation?
- Can surgical complications caused by the 3-steps standardized repair-oriented strategy be non-inferior (clinically acceptable) to annuloplasty only? Participants will be assigned to either the Standardized Group (including subvalvular apparatus rehabilitation (leaflet plication if chordae absent on leaflet margin, mal-connected chordae resection if chordae mal-connected to leaflet body, papillary muscle splitting if short chordae or dysplastic or fused papillary muscle etc.), leaflets repair (leaflets plication if functional leaflet prolapse, leaflet cleft closure and patch augmentation for anatomical leaflet defect, etc.) and annuloplasty (posterior annuloplasty for annular dilatation and shallow leaflet coaptation, etc.)) or the Annuloplasty Group (annuloplasty only during mitral repair surgeries. Additionally, echocardiography, electrocardiograms, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of surgery and at 1 months, 3 months, and 6 months after mitral repair.
Researchers will compare the Standardized Group and the Annuloplasty Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 6 months of surgery, is lower in the former than in the latter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized Group | – | Procedure: 3-steps standardized repair-oriented strategyPatients in this group will undergo standardized strategy during mitral repair surgeries, including subvalvular apparatus rehabilitation, leaflets repair and annuloplasty. |
| Annuloplasty Group | – | –Patients in this group will undergo annuloplasty only during mitral repair surgeries. |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under the age of 14 with moderate to severe mitral valve regurgitation
Key inclusion criteria (3 listed)
- < 14 years old
- had not undertake mitral valve surgery before
- moderate to severe mitral regurgitation
Key exclusion criteria (10 listed)
- moderate to severe mitral regurgitation which concommitant with other cardiac malformation which can not be correct or can only perform palliative surgery
- concommitant with mitral stenosis
- ischemic mitral regurgitation (for example, concommitant with anomalous origin of coronary artery)
- Barlow syndrome
- dysplasia of mitral leaflet
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 |
|---|---|---|
| 3-steps standardized repair-oriented strategy3-steps standardized repair-oriented strategy, including subvalvular apparatus rehabilitation (leaflet plication if chordae absent on leaflet margin, mal-connected chordae resection if chordae mal-connected to leaflet body, papillary muscle splitting if short chordae or dysplastic or fused papillary muscle etc.), leaflets repair (leaflets plication if functional leaflet prolapse, leaflet cleft closure and patch augmentation for anatomical leaflet defect, etc.) and annuloplasty (posterior annuloplasty for annular dilatation and shallow leaflet coaptation, etc.) | Procedure or surgery | Standardized Group |
Primary outcome
the recurrence rate of moderate to severe mitral valve regurgitation
Time frame: after 6 months of surgery
During follow-up visits, echocardiographic examination is conducted to measure the degree of mitral valve regurgitation. If it falls within the moderate to severe range, it is recorded as a recurrence.
5 secondary outcomes
Improvement in symptoms
Time frame: after 6 months of surgery
Change in left ventricular function
Time frame: after 6 months of surgery
Change in left ventricular function
Time frame: after 6 months of surgery
NT-proBNP level
Time frame: after 6 months of surgery
Incidence rate of surgical complications
Time frame: after 6 months of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Shoujun Li, MD study chair
Chinese Academy of Medical Sciences, Fuwai Hospital
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 Congenital Mitral Insufficiency, 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 10 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: status not confirmed, as of the sponsor's last update on 15 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Ma, PhD (+86 15901428497, drmakaifw@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the recurrence rate of moderate to severe mitral valve regurgitation (time frame: after 6 months of surgery). 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 15 Sep 2023.