Diseases of Mitral ValveNCT02505074
Natural History of Melody Valve in the Mitral and Tricuspid Position
An observational study of Diseases of Mitral Valve and Tricuspid Valve Disorder, run by Boston Children's Hospital.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Diseases of Mitral Valve, Tricuspid Valve Disorder
- What is being tested?
- Valve replacement with the Melody valve
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- All patients who have had a Melody valve inserted into either mitral or tricuspid positions via surgical intervention
Who cannot join
- There are no exclusion criteria.
About this study
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.
Read the 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.
- Conditions
- Diseases of Mitral Valve, Tricuspid Valve Disorder
- Being tested
- Valve replacement with the Melody valve
- Keywords
- mitral valve, tricuspid valve, Melody valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valve replacement with the Melody valveProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Mitral Valve Replacement | Review of retrospective data of those patients who have had surgical replacement of the mitral valve with the Melody valve. Receives: 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. Receives: Procedure: Valve replacement with the Melody valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term durability of Melody Valve in mitral and tricuspid positions, to be measured by degree of stenosis in Melody valve
Measured: 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
Measured: 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
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startDec 2014
- Primary completionJan 2024
- Study completionJun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diseases of Mitral ValveStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MOUNT SINAI HOSPITAL, Children's Hospital and Medical Center, University of California, San Francisco, NewYork Presbyterian Hospital, 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, Fondation IUCPQ, Hospital for Sick Kids
- Responsible party
- Principal investigator, Sitaram Emani, Boston Children's Hospital
- Investigators
- Sitaram Emani, MD, Principal investigator, Cardiovascular Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505074
- Sponsor's protocol ID
- IRB-P00015805
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2015
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24332108Hasan 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.
PubMed 22075926Kaza 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.
PubMed 19660342Pluchinotta 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.
PubMed 30571200
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Melody Valve in the Mitral and Tricuspid Position
- ClinicalTrials.gov ID
- NCT02505074
- Acronym / sponsor ID
- IRB-P00015805
- Conditions
- Diseases of Mitral Valve, Tricuspid Valve Disorder
- Keywords
- mitral valve, tricuspid valve, Melody valve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- MOUNT SINAI HOSPITAL, Children's Hospital and Medical Center, University of California, San Francisco, NewYork Presbyterian Hospital, 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, Fondation IUCPQ, Hospital for Sick Kids
- Study start
- Dec 2014
- Primary completion
- Jan 2024 (actual)
- Study completion
- Jun 2025 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitral Valve Replacement | – | Procedure: Valve replacement with the Melody valveReview of retrospective data of those patients who have had surgical replacement of the mitral valve with the Melody valve. |
| Tricuspid Valve Replacement | – | Procedure: Valve replacement with the Melody valveReview of retrospective data of those patients who have had surgical replacement of the tricuspid valve with the Melody valve. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- All patients who have had a Melody valve inserted into either mitral or tricuspid positions via surgical intervention
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valve replacement with the Melody valveThis 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. | Procedure or surgery | Mitral Valve Replacement, Tricuspid Valve Replacement |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 24332108Quinonez 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.
- Background: PubMed 22075926Hasan 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.
- Background: PubMed 19660342Kaza 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.
- Derived from this study: PubMed 30571200Pluchinotta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sitaram Emani, MD principal investigator
Cardiovascular Surgeon
Questions about this trial
What is this clinical trial studying?
An observational study of Diseases of Mitral Valve and Tricuspid Valve Disorder, run by Boston Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02505074, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.