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Natural History of Melody Valve in the Mitral and Tricuspid Position

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ClinicalTrials.gov Identifier: NCT02505074
Recruitment Status : Active, not recruiting
First Posted : July 22, 2015
Last Update Posted : March 1, 2018
Sponsor:
Collaborators:
Mount Sinai Hospital, New York
Children's Hospital and Medical Center
University of California, San Francisco
NewYork Presbyterian Hospital
The Monroe Carell Jr. Children's Hospital at Vanderbilt
Northwell Health
Primary Children's Hospital
Seattle Children's Hospital
Gruppo Ospedaliero San Donato
University Hospital Munich
University Children's Hospital, Zurich
IUCPQ et CHU de Quebec
Hospital for Sick Kids
Information provided by (Responsible Party):
Sitaram Emani, 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.


Condition or disease Intervention/treatment
Diseases of Mitral Valve Tricuspid Valve Disorder Procedure: Valve replacement with the Melody valve

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Natural History of Melody Valve in the Mitral and Tricuspid Position
Study Start Date : December 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Group/Cohort Intervention/treatment
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
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.

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
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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505074


Sponsors and Collaborators
Boston Children’s Hospital
Mount Sinai Hospital, New York
Children's Hospital and Medical Center
University of California, San Francisco
NewYork Presbyterian Hospital
The Monroe Carell Jr. Children's Hospital at Vanderbilt
Northwell Health
Primary Children's Hospital
Seattle Children's Hospital
Gruppo Ospedaliero San Donato
University Hospital Munich
University Children's Hospital, Zurich
IUCPQ et CHU de Quebec
Hospital for Sick Kids
Investigators
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Principal Investigator: Sitaram Emani, MD Cardiovascular Surgeon

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sitaram Emani, Cardiovascular Surgeon, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02505074     History of Changes
Other Study ID Numbers: IRB-P00015805
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

Keywords provided by Sitaram Emani, Boston Children’s Hospital:
mitral valve
tricuspid valve
Melody valve

Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases