Heart Valve DiseasesNCT00688571
Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study
A study testing Melody Transcatheter Pulmonary Valve in people with Heart Valve Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites in 6 countries.
Trial summary
This non-randomized, prospective, interventional observational multi-center study is designed to assess the long-term clinical performance of the Medtronic Melody™ Transcatheter Pulmonary Valve (TPV) in the post market environment over a period of five years after transcatheter implantation in patients with… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- Melody Transcatheter Pulmonary Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Oct 2007to Dec 2014
- Phase
- Interventional
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than or equal to 5 years of age
- Weight greater than or equal to 30 kilograms
- Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted
- Any of the following by transthoracic echocardiography
- For patients in NYHA Classification II, III, or IV:
- Moderate (3+) or severe (4+) pulmonary regurgitation, or
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- Mean RVOT gradient greater than or equal to 35 mmHg.
- For patients in NYHA Classification I:
- Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction, or
- Mean RVOT gradient greater than or equal to 40 mmHg.
Who cannot join
- Active endocarditis
- A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
- Patient or - for patients who cannot legally give consent themselves- the guardian unwilling or unable to provide written informed consent or comply with follow-up requirements
- Obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the delivery system cannot be advanced to the heart via transvenous approach from either femoral vein or internal jugular vein
- Known intravenous drug abuse
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Germany2 sites
Deutsches Herzzentrum Berlin
Berlin, 13353
Deutsches Herzzentrum München
München, 80636
About this study
Official title: Melody TPV Post-Market Surveillance Study
This non-randomized, prospective, interventional observational multi-center study is designed to assess the long-term clinical performance of the Medtronic Melody™ Transcatheter Pulmonary Valve (TPV) in the post market environment over a period of five years after transcatheter implantation in patients with dysfunctional RVOT conduits. In addition, the quality of life of implanted subjects will be assessed over five years.
- Conditions
- Heart Valve Diseases
- Being tested
- Melody Transcatheter Pulmonary Valve
- Keywords
- Pulmonary Valve, Congenital Heart Disease
- Medical subject headings
- Heart Valve Diseases, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melody Transcatheter Pulmonary ValveDevice
Transcatheter valve implantation into a RV-PA conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs intervention
| Study group | Role | What they receive |
|---|---|---|
| Melody TPV Implant | Experimental | Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RV-PV conduit. Receives: Device: Melody Transcatheter Pulmonary Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance over five years. Freedom from the following events: * explant * reintervention * stent fracture * valve dysfunction * device or procedure related death
Measured: August 2014
Secondary outcomes (3)
Procedural success
Measured: August 2014
Incidence of device and procedure related adverse events
Measured: August 2014
Hemodynamic Performance
Measured: August 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- John Hess, Prof., Principal investigator, Deutsches Herzzentrum MünchenFelix Berger, Prof., Principal investigator, German Heart InstituteLars Soendergaard, Dr., Principal investigator, Copenhagen University Hospital, RigshospitaletMaria Giulia Gagliardi, Dr., Principal investigator, Ospedale Bambino Gesu RomeJose Suarez de Lezo, Dr., Principal investigator, Hospital Reina Sofia CordobaLee Benson, Dr., Principal investigator, The Hospital for Sick ChildrenMaarten Witsenburg, Dr., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688571
- Sponsor's protocol ID
- BRC-CS-PMSS
- Status last verified
- Oct 2015
- First submitted
- 30 May 2008
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Armstrong AK, Berger F, Jones TK, Moore JW, Benson LN, Cheatham JP, Turner DR, Rhodes JF, Vincent JA, Zellers T, Lung TH, Eicken A, McElhinney DB. Association between patient age at implant and outcomes after transcatheter pulmonary valve replacement in the multicenter Melody valve trials. Catheter Cardiovasc Interv. 2019 Oct 1;94(4):607-617. doi: 10.1002/ccd.28454. Epub 2019 Aug 16.
PubMed 31419019McElhinney DB, Benson LN, Eicken A, Kreutzer J, Padera RF, Zahn EM. Infective endocarditis after transcatheter pulmonary valve replacement using the Melody valve: combined results of 3 prospective North American and European studies. Circ Cardiovasc Interv. 2013 Jun;6(3):292-300. doi: 10.1161/CIRCINTERVENTIONS.112.000087. Epub 2013 Jun 4.
PubMed 23735475
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melody TPV Post-Market Surveillance Study
- ClinicalTrials.gov ID
- NCT00688571
- Acronym / sponsor ID
- BRC-CS-PMSS
- Conditions
- Heart Valve Diseases
- Keywords
- Pulmonary Valve, Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Oct 2007
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Jun 2008 (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.
This non-randomized, prospective, interventional observational multi-center study is designed to assess the long-term clinical performance of the Medtronic Melody™ Transcatheter Pulmonary Valve (TPV) in the post market environment over a period of five years after transcatheter implantation in patients with dysfunctional RVOT conduits. In addition, the quality of life of implanted subjects will be assessed over five years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melody TPV Implant | Experimental | Device: Melody Transcatheter Pulmonary ValveMelody Transcatheter Pulmonary Valve implanted into a dysfunctional RV-PV conduit. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age greater than or equal to 5 years of age
- Weight greater than or equal to 30 kilograms
- Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted
- Any of the following by transthoracic echocardiography
- Moderate (3+) or severe (4+) pulmonary regurgitation, or
Key exclusion criteria (5 listed)
- Active endocarditis
- A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
- Patient or - for patients who cannot legally give consent themselves- the guardian unwilling or unable to provide written informed consent or comply with follow-up requirements
- Obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the delivery system cannot be advanced to the heart via transvenous approach from either femoral vein or internal jugular vein
- Known intravenous drug abuse
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 |
|---|---|---|
| Melody Transcatheter Pulmonary ValveTranscatheter valve implantation into a RV-PA conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs intervention | Device | Melody TPV Implant |
Primary outcome
Clinical Performance over five years. Freedom from the following events: * explant * reintervention * stent fracture * valve dysfunction * device or procedure related death
Time frame: August 2014
3 secondary outcomes
Procedural success
Time frame: August 2014
Incidence of device and procedure related adverse events
Time frame: August 2014
Hemodynamic Performance
Time frame: August 2014
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 29 Oct 2015.
- Derived from this study: PubMed 31419019Armstrong AK, Berger F, Jones TK, Moore JW, Benson LN, Cheatham JP, Turner DR, Rhodes JF, Vincent JA, Zellers T, Lung TH, Eicken A, McElhinney DB. Association between patient age at implant and outcomes after transcatheter pulmonary valve replacement in the multicenter Melody valve trials. Catheter Cardiovasc Interv. 2019 Oct 1;94(4):607-617. doi: 10.1002/ccd.28454. Epub 2019 Aug 16.
- Derived from this study: PubMed 23735475McElhinney DB, Benson LN, Eicken A, Kreutzer J, Padera RF, Zahn EM. Infective endocarditis after transcatheter pulmonary valve replacement using the Melody valve: combined results of 3 prospective North American and European studies. Circ Cardiovasc Interv. 2013 Jun;6(3):292-300. doi: 10.1161/CIRCINTERVENTIONS.112.000087. Epub 2013 Jun 4.
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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.
John Hess, Prof. principal investigator
Deutsches Herzzentrum München
Felix Berger, Prof. principal investigator
German Heart Institute
Lars Soendergaard, Dr. principal investigator
Copenhagen University Hospital, Rigshospitalet
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melody Transcatheter Pulmonary Valve in people with Heart Valve Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites in 6 countries.
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 10 inclusion and 5 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 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Canada, Denmark, Italy, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Clinical Performance over five years. Freedom from the following events: * explant * reintervention * stent fracture * valve dysfunction * device or procedure related death (time frame: August 2014). 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 NCT00688571, which also lists 2 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 29 Oct 2015; AzTrials last refreshed its copy on 7 Nov 2026.