Right Ventricular Congenital Cardiopathies Clinical Trial
— Melody™FROfficial title:
Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™
| Verified date | September 2020 |
| Source | Medtronic Bakken Research Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 409 |
| Est. completion date | October 20, 2013 |
| Est. primary completion date | January 24, 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Patients requiring pulmonary valvular replacement for correction of right ventricular ejection path malfunction (stenosis and/or pulmonary regurgitation). Exclusion Criteria: - Patient or legal representative refusal to data collection or processing - Patient unable to guarantee follow-up data collection, in particular for patients living abroad |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Louis Pradel | Bron | |
| France | Hôpital Gabriel Montpied | Clermont-Ferrand | |
| France | Centre chirurgical Marie Lannelongue | Le Plessis-Robinson | |
| France | Hôpital Cardiologique | Lille | |
| France | Hôpital de La Timone Enfants | Marseille | |
| France | Hôpital Laënnec | Nantes | |
| France | Hôpital des enfants Malades Necker | Paris | |
| France | Hôpital Cardiologique du Haut-Lévêque | Pessac | |
| France | Clinique Pasteur | Toulouse | |
| France | Hôpital des enfants Purpan | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic Bakken Research Center |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 12 months | |
| Secondary | rate re-intervention on the valve | To document the rate re-intervention on the valve during a 60 months follow-up after its implantation | 60 months | |
| Secondary | 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) | 60 months | |
| Secondary | patient characteristics | To compare the patient characteristics to the indications of the bioprosthesis | 60 months | |
| Secondary | 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 | 60 months | |
| Secondary | failures of the implantation procedure | To document the failures of the implantation procedure | 60 months | |
| Secondary | survival rate at 12, 36, 48 and 60 months | To document the survival rate at 12, 36, 48 and 60 months | 60 months | |
| Secondary | frequency of antiplatelet treatment during and after implant | To describe the frequency of antiplatelet treatment during and after implant | 60 months | |
| Secondary | patients' characteristics to indications of the MELODY™ bioprosthesis | To compare patients' characteristics to indications of the MELODY™ bioprosthesis | 60 months | |
| Secondary | 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 | 60 months |