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OpenTrials
Completed

NCT Number: NCT02505074

Natural History of Melody Valve in the Mitral and Tricuspid Position

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.

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Key information

Conditions

Diseases of Mitral Valve Tricuspid Valve Disorder

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • There are no exclusion criteria.

Treatment and study plan

Valve replacement with the Melody valve

Procedure

This study will only review patients who have had the Melody valve surgically inserted into the Mitral and/or Tricuspid positions. We will not be reviewing any other intervention type.

Primary outcomes

  1. Long term durability of Melody Valve in mitral and tricuspid positions, to be measured by degree of stenosis in Melody valve

    Time frame: up to 5 years

  2. Long term durability of Melody Valve in mitral and tricuspid positions, to be measured by grade of regurgitation in Melody valve

    Time frame: up to 5 years

  3. Long term durability of Melody Valve in mitral and tricuspid positions, to be measured by number of necessary re-interventions of Melody valve

    Time frame: up to 5 years

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Children's Hospital and Medical Center
  • Fondation IUCPQ
  • Gruppo Ospedaliero San Donato
  • Hospital for Sick Kids
  • MOUNT SINAI HOSPITAL
  • Monroe Carell Jr. Children's Hospital at Vanderbilt
  • NewYork Presbyterian Hospital
  • Northwell Health
  • Primary Children's Hospital
  • Seattle Children's Hospital
  • University Children's Hospital, Zurich
  • University Hospital Munich
  • University of California, San Francisco

Registry information

Important dates

Study start
2014
Primary completion
2024
Study completion
2025
First posted
Jul 22, 2015
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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