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Study of Innovative Strategies for Mitral Valve Repair

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ClinicalTrials.gov Identifier: NCT06037447
Recruitment Status : Recruiting
First Posted : September 14, 2023
Last Update Posted : September 15, 2023
Sponsor:
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
Fuwai Central China Cardiovascular Hospital, Zhengzhou, China
Information provided by (Responsible Party):
Shoujun Li, China National Center for Cardiovascular Diseases

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment
Congenital Mitral Insufficiency Procedure: 3-steps standardized repair-oriented strategy

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 256 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
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
Actual Study Start Date : April 1, 2022
Estimated Primary Completion Date : April 5, 2024
Estimated Study Completion Date : December 31, 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
Standardized Group
Patients in this group will undergo standardized strategy during mitral repair surgeries, including subvalvular apparatus rehabilitation, leaflets repair and annuloplasty.
 Procedure: 3-steps standardized repair-oriented strategy
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.)
Annuloplasty Group
Patients in this group will undergo annuloplasty only during mitral repair surgeries.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Improvement in symptoms [ Time Frame: after 6 months of surgery ]
    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.

  2. Change in left ventricular function [ Time Frame: after 6 months of surgery ]
    Based on the echocardiogram, measurements are taken for left ventricular ejection fraction.

  3. Change in left ventricular function [ Time Frame: after 6 months of surgery ]
    Based on the echocardiogram, measurements are taken for left ventricular end-diastolic diameter.

  4. NT-proBNP level [ Time Frame: after 6 months of surgery ]
    The trend in NT-proBNP levels.

  5. Incidence rate of surgical complications [ Time Frame: after 6 months of surgery ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children under the age of 14 with moderate to severe mitral valve regurgitation
Criteria

Inclusion Criteria:

  • < 14 years old
  • had not undertake mitral valve surgery before
  • moderate to severe mitral regurgitation

Exclusion Criteria:

  • 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
  • common atrioventricular valve
  • atrioventricular common channel
  • cardiomyopathy
  • other mitral valve surgery contraindications
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06037447


Contacts
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Contact: Kai Ma, PhD +86 15901428497 drmakaifw@yahoo.com
Contact: Zheng Dou, PhD +86 18810673618 drdouzheng@163.com

Locations
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China, Beijing
Fuwai hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Shoujun Li, MD    +86 13501071589    drlishoujunfw@163.com   
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
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
Fuwai Central China Cardiovascular Hospital, Zhengzhou, China
Investigators
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Study Chair: Shoujun Li, MD Fuwai Hospital
More Information
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Responsible Party: Shoujun Li, Director of Congenital Heart Surgery Center, China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT06037447    
Other Study ID Numbers: 2022-GSP-GG-19-2
First Posted: September 14, 2023    Key Record Dates
Last Update Posted: September 15, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Shoujun Li, China National Center for Cardiovascular Diseases:
congenital heart disease
mitral regurgitation
mitral valve repair
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases