Clinical trial NCT02505074: Natural History of Melody Valve in the Mitral and Tricuspid Position
Official title: Natural History of Melody Valve in the Mitral and Tricuspid Position
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diseases of Mitral Valve
Tricuspid Valve Disorder
Keywords: mitral valve
tricuspid valve
Melody valve
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: MOUNT SINAI HOSPITAL
name: Children's Hospital and Medical Center
name: University of California, San Francisco
name: NewYork Presbyterian Hospital
name: The Monroe Carell Jr. Children's Hospital at Vanderbilt
name: Northwell Health
name: Primary Children's Hospital
name: Seattle Children's Hospital
name: Gruppo Ospedaliero San Donato
name: University Hospital Munich
name: University Children's Hospital, Zurich
name: Fondation IUCPQ
name: Hospital for Sick Kids
First posted: 2015-07-22
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have had a Melody valve inserted via surgical intervention prior to December, 2014, into either the mitral or tricuspid positions, will be eligible.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Long term durability of Melody Valve in mitral and tricuspid positions, to be measured by degree of stenosis in Melody valve
timeFrame: up to 5 years
measure: Long term durability of Melody Valve in mitral and tricuspid positions, to be measured by grade of regurgitation in Melody valve
timeFrame: up to 5 years
measure: Long term durability of Melody Valve in mitral and tricuspid positions, to be measured by number of necessary re-interventions of Melody valve
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cardiovascular Surgeon
name: Sitaram Emani, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
citation: Pluchinotta FR, Piekarski BL, Milani V, Kretschmar O, Burch PT, Hakami L, Meyer DB, Jacques F, Ghez O, Trezzi M, Carotti A, Qureshi SA, Michel-Behnke I, Hammel JM, Chai P, McMullan D, Mettler B, Ferrer Q, Carminati M, Emani SM. Surgical Atrioventricular Valve Replacement With Melody Valve in Infants and Children. Circ Cardiovasc Interv. 2018 Nov;11(11):e007145. doi: 10.1161/CIRCINTERVENTIONS.118.007145.