Natural History of Melody Valve in the Mitral and Tricuspid Position

Diseases of Mitral Valve Clinical Trial

Official title:

Natural History of Melody Valve in the Mitral and Tricuspid Position

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02505074
• Other study ID #: IRB-P00015805
• Status: Active, not recruiting
• Start date: December 2014
• Est. completion date: June 2025

Study information

• Verified date: January 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diseases of Mitral Valve
• Tricuspid Valve Disorder

Intervention

Procedure:
• Valve replacement with the Melody valve
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.

Locations

Country	Name	City	State
n/a

Sponsors (14)

Lead Sponsor

Collaborator

Boston Children's Hospital

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

References & Publications (3)

Hasan BS, McElhinney DB, Brown DW, Cheatham JP, Vincent JA, Hellenbrand WE, Jones TK, Zahn EM, Lock JE. Short-term performance of the transcatheter Melody valve in high-pressure hemodynamic environments in the pulmonary and systemic circulations. Circ Cardiovasc Interv. 2011 Dec 1;4(6):615-20. doi: 10.1161/CIRCINTERVENTIONS.111.963389. Epub 2011 Nov 9. — View Citation

Kaza AK, Lim HG, Dibardino DJ, Bautista-Hernandez V, Robinson J, Allan C, Laussen P, Fynn-Thompson F, Bacha E, del Nido PJ, Mayer JE Jr, Pigula FA. Long-term results of right ventricular outflow tract reconstruction in neonatal cardiac surgery: options and outcomes. J Thorac Cardiovasc Surg. 2009 Oct;138(4):911-6. doi: 10.1016/j.jtcvs.2008.10.058. Epub 2009 Jul 26. — View Citation

Quinonez LG, Breitbart R, Tworetsky W, Lock JE, Marshall AC, Emani SM. Stented bovine jugular vein graft (Melody valve) for surgical mitral valve replacement in infants and children. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1443-9. doi: 10.1016/j.jtcvs.2013.10.059. Epub 2013 Dec 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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