Natural History of Melody Valve in the Mitral and Tricuspid Position

Active, not recruiting

• Conditions: Tricuspid Valve Disorder; Diseases of Mitral Valve
• Interventions: Procedure: Valve replacement with the Melody valve

• Registration Number: NCT02505074
• Lead Sponsor: Boston Children's Hospital

Brief Summary

The Melody valve has historically been used for pulmonary valve replacements; however it has been more recently used in the mitral and tricuspid positions. This multi-center, retrospective, observational study will review the durability of the Melody valve inserted into the mitral or tricuspid positions.

Patients who have undergone Melody valve insertion into either the mitral or tricuspid positions prior to December, 2014 will be eligible for the study. Basic de-identified patient demographics will be collected as well as select clinical data. Ventricular function and valvar function of the affected valve will be retrospectively reviewed both prior to surgery and following, as well as review of operative data. The investigators will also review the most recent follow up data and any subsequent re-interventions on the Melody valve. Data from all sites will be entered into an external REDCap database, using only de-identified data.

Detailed Description

Prior to recent advancement in using the Melody valve for atrioventricular valve replacement, there have only been fixed diameter valve options for severe valve disease requiring replacement. This presents numerous obstacles for those pediatric patients who require replacement early in life, as the fixed diameter does not offer options for expansion for somatic growth, and early reoperation will be required.

The Melody valve has been approved for transcatheter implantation into the RVOT (right ventricular outflow tract), and has shown competence within a range of sizes. Recent studies conducted at Boston Children's Hospital of off-label use of the Melody valve into atrioventricular valve positions have shown acceptable short-term valve performance, and that subsequent catheter-based expansion is feasible.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-06-29
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-22
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-11
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All patients who have had a Melody valve inserted into either mitral or tricuspid positions via surgical intervention

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Exclusion Criteria

• There are no exclusion criteria.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mitral Valve Replacement	Valve replacement with the Melody valve	Review of retrospective data of those patients who have had surgical replacement of the mitral valve with the Melody valve.
Tricuspid Valve Replacement	Valve replacement with the Melody valve	Review of retrospective data of those patients who have had surgical replacement of the tricuspid valve with the Melody valve.

Primary Outcome Measures

Name	Time	Method
Long term durability of Melody Valve in mitral and tricuspid positions, to be measured by degree of stenosis in Melody valve	up to 5 years
Long term durability of Melody Valve in mitral and tricuspid positions, to be measured by grade of regurgitation in Melody valve	up to 5 years
Long term durability of Melody Valve in mitral and tricuspid positions, to be measured by number of necessary re-interventions of Melody valve	up to 5 years