Study of Innovative Strategies for Mitral Valve Repair

Recruiting

• Conditions: Congenital Mitral Insufficiency
• Interventions: Procedure: 3-steps standardized repair-oriented strategy

• Registration Number: NCT06037447
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-07
• Last Update Submitted: 2023-09-13
• Study First Posted: 2023-09-14
• Last Update Posted: 2023-09-15
• Primary Completion: 2024-04-05
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 256

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standardized Group	3-steps standardized repair-oriented strategy	Patients in this group will undergo standardized strategy during mitral repair surgeries, including subvalvular apparatus rehabilitation, leaflets repair and annuloplasty.

Primary Outcome Measures

Name	Time	Method
the recurrence rate of moderate to severe mitral valve regurgitation	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

Name	Time	Method
NT-proBNP level	after 6 months of surgery	The trend in NT-proBNP levels.
Improvement in symptoms	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.
Change in left ventricular function	after 6 months of surgery	Based on the echocardiogram, measurements are taken for left ventricular end-diastolic diameter.
Incidence rate of surgical complications	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).

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, Beijing, China