Study of Innovative Strategies for Mitral Valve Repair

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:

• 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 Overview

• Status: Recruiting
• Conditions: Congenital Mitral Insufficiency
• Intervention / Treatment: Procedure: 3-steps standardized repair-oriented strategy

• Study Type: Observational
• Enrollment (Estimated): 256

Contacts and Locations

• Study Contact: Name: Kai Ma, PhD; Phone Number: +86 15901428497; Email: drmakaifw@yahoo.com
• Study Contact Backup: Name: Zheng Dou, PhD; Phone Number: +86 18810673618; Email: drdouzheng@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Fuwai Hospital
      • Contact: Shoujun Li, MD; Phone Number: +86 13501071589; Email: drlishoujunfw@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	after 6 months of surgery
NT-proBNP level	The trend in NT-proBNP levels.	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).	after 6 months of surgery
Change in left ventricular function	Based on the echocardiogram, measurements are taken for left ventricular ejection fraction.	after 6 months of surgery
Change in left ventricular function	Based on the echocardiogram, measurements are taken for left ventricular end-diastolic diameter.	after 6 months of surgery

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• 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
• Investigators: Study Chair: Shoujun Li, MD, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): April 5, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: mitral valve repair; mitral regurgitation; congenital heart disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 2022-GSP-GG-19-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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