Natural History of Melody Valve in the Mitral and Tricuspid Position

NCT02505074 | Unknown

• 1 other identifier: IRB-P00015805
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diseases of Mitral Valve; Tricuspid Valve Disorder

Keywords

mitral valve; tricuspid valve; Melody valve

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Mitral Valve Replacement

Review of retrospective data of those patients who have had surgical replacement of the mitral valve with the Melody valve.

Procedure: Valve replacement with the Melody valve

Tricuspid Valve Replacement

Review of retrospective data of those patients who have had surgical replacement of the tricuspid valve with the Melody valve.

Procedure: Valve replacement with the Melody valve

Interventions

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.

Mitral Valve Replacement; Tricuspid Valve Replacement

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

Sponsors & Collaborators

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

Related Publications (4)

• 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.

  PMID: 24332108 BACKGROUND

• 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.

  PMID: 22075926 BACKGROUND

• 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.

  PMID: 19660342 BACKGROUND

• 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.

  PMID: 30571200 DERIVED

Study Officials

• Sitaram Emani, MD

  Cardiovascular Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiovascular Surgeon

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 22, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: January 11, 2023

Record last verified: 2023-01