Right Ventricular Congenital CardiopathiesMelody™FRNCT02023775
Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™
An observational study of Right Ventricular Congenital Cardiopathies, run by Medtronic Cardiac Rhythm and Heart Failure at 10 sites in France.
Trial summary
Prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period. This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Right Ventricular Congenital Cardiopathies
- What is being tested?
- Melody valve implantation
- Type of treatment
- Medical device
- How many people
- 409 participants
- Where
- 10 sitesFrance
- Study dates
- 31 Jan 2010to 20 Oct 2013
- How long will I take part?
- 3 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients receiving a valve implantation, without exception (exhaustive population)
Who may be able to join
- Patients requiring pulmonary valvular replacement for correction of right ventricular ejection path malfunction (stenosis and/or pulmonary regurgitation).
Who cannot join
- Patient or legal representative refusal to data collection or processing
- Patient unable to guarantee follow-up data collection, in particular for patients living abroad
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Hôpital Louis Pradel
Bron, 69677
Hôpital Gabriel Montpied
Clermont-Ferrand, 63003
Centre chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350
Hôpital Cardiologique
Lille, 59037
Hôpital de La Timone Enfants
Marseille, 13385
Hôpital Laënnec
Nantes, 44800
Hôpital des enfants Malades Necker
Paris, 75015
Hôpital Cardiologique du Haut-Lévêque
Pessac, 33604
Hôpital des enfants Purpan
Toulouse, 31059
Clinique Pasteur
Toulouse, 31076
About this study
Prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period.
This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France.
Read the detailed description
This is a prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period in France. The study is requested by French Health Authorities in 2010 for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France. The study was closed in 2013.
- Being tested
- Melody valve implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melody valve implantationDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients implanted with Medtronic Melody valve | All patients that received a valve implantation were included in the registry. Receives: Device: Melody valve implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
absence of re-intervention on the pulmonary valve
to evaluate the efficacy of the MELODY valve, defined as the absence of re-intervention on the pulmonary valvee
Measured: 12 months
Secondary outcomes (9)
rate re-intervention on the valve
To document the rate re-intervention on the valve during a 60 months follow-up after its implantation
Measured: 60 months
time period before re-intervention on the valve
To document the time period before re-intervention on the valve (longevity of the prosthesis), the reasons for re-intervention (stent fracture, leak, stenosis) and the rate of durability (% of implanted valves with malfunction requiring a re-intervention)
Measured: 60 months
patient characteristics
To compare the patient characteristics to the indications of the bioprosthesis
Measured: 60 months
Description and time of onset of open surgery after implantation
Description and time of onset of open surgery after implantation on first implanted patients versus device replacement
Measured: 60 months
failures of the implantation procedure
To document the failures of the implantation procedure
Measured: 60 months
survival rate at 12, 36, 48 and 60 months
To document the survival rate at 12, 36, 48 and 60 months
Measured: 60 months
frequency of antiplatelet treatment during and after implant
To describe the frequency of antiplatelet treatment during and after implant
Measured: 60 months
patients' characteristics to indications of the MELODY™ bioprosthesis
To compare patients' characteristics to indications of the MELODY™ bioprosthesis
Measured: 60 months
time period before the resumption of professional, university or scholastic activity
To document the time period before the resumption of professional, university or scholastic activity
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study start31 Jan 2010
- Primary completion24 Jan 2013
- Study completion20 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Ventricular Congenital CardiopathiesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 409 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sophie MALEKZADEH-MILANI, MD, Principal investigator, Hôpital des enfants Malades - Necker, 149 rue de Sèvres, 75015 Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023775
- Sponsor's protocol ID
- Melody™ France
- Acronym
- Melody™FR
- Status last verified
- Sep 2020
- First submitted
- 29 Apr 2013
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™
- ClinicalTrials.gov ID
- NCT02023775
- Acronym / sponsor ID
- Melody™FR / Melody™ France
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2010 (actual)
- Primary completion
- 24 Jan 2013 (actual)
- Study completion
- 20 Oct 2013 (actual)
- First posted
- 30 Dec 2013 (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.
Prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period.
This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France.
Detailed description
This is a prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period in France. The study is requested by French Health Authorities in 2010 for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France. The study was closed in 2013.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients implanted with Medtronic Melody valve | – | Device: Melody valve implantationAll patients that received a valve implantation were included in the registry. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients receiving a valve implantation, without exception (exhaustive population)
Key inclusion criteria (1 listed)
- Patients requiring pulmonary valvular replacement for correction of right ventricular ejection path malfunction (stenosis and/or pulmonary regurgitation).
Key exclusion criteria (2 listed)
- Patient or legal representative refusal to data collection or processing
- Patient unable to guarantee follow-up data collection, in particular for patients living abroad
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 valve implantation | Device | Patients implanted with Medtronic Melody valve |
Primary outcome
absence of re-intervention on the pulmonary valve
Time frame: 12 months
to evaluate the efficacy of the MELODY valve, defined as the absence of re-intervention on the pulmonary valvee
9 secondary outcomes
rate re-intervention on the valve
Time frame: 60 months
time period before re-intervention on the valve
Time frame: 60 months
patient characteristics
Time frame: 60 months
Description and time of onset of open surgery after implantation
Time frame: 60 months
failures of the implantation procedure
Time frame: 60 months
survival rate at 12, 36, 48 and 60 months
Time frame: 60 months
frequency of antiplatelet treatment during and after implant
Time frame: 60 months
patients' characteristics to indications of the MELODY™ bioprosthesis
Time frame: 60 months
time period before the resumption of professional, university or scholastic activity
Time frame: 60 months
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 3 Jul 2025.
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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.
Sophie MALEKZADEH-MILANI, MD principal investigator
Hôpital des enfants Malades - Necker, 149 rue de Sèvres, 75015 Paris, France
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Ventricular Congenital Cardiopathies, run by Medtronic Cardiac Rhythm and Heart Failure at 10 sites in France.
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 2 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 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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?
absence of re-intervention on the pulmonary valve (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2025.