Study of Innovative Strategies for Mitral Valve Repair

NCT06037447 | Unknown

• 1 other identifier: 2022-GSP-GG-19-2
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Mitral Insufficiency

Keywords

congenital heart disease; mitral regurgitation; mitral valve repair

Outcome Measures

Primary Outcomes (1)

• 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.

  after 6 months of surgery

Secondary Outcomes (5)

• Improvement in symptoms

  after 6 months of surgery

• Change in left ventricular function

  after 6 months of surgery

• Change in left ventricular function

  after 6 months of surgery

• NT-proBNP level

  after 6 months of surgery

• Incidence rate of surgical complications

  after 6 months of surgery

Study Arms (2)

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

Annuloplasty Group

Patients in this group will undergo annuloplasty only during mitral repair surgeries.

Interventions

3-steps standardized repair-oriented strategy PROCEDURE

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.)

Standardized Group

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children under the age of 14 with moderate to severe mitral valve regurgitation

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Shanghai Children's Medical Center: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Guangzhou Women and Children's Medical Center: collaborator
• Children's Hospital of Chongqing Medical University: collaborator

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Valve Diseases

Study Officials

• Shoujun Li, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY CHAIR

Central Study Contacts

Kai Ma, PhD

CONTACT

+86 15901428497; drmakaifw@yahoo.com

Zheng Dou, PhD

CONTACT

+86 18810673618; drdouzheng@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Congenital Heart Surgery Center

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: April 1, 2022
• Primary Completion: April 5, 2024
• Study Completion: December 31, 2024
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)