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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients implanted with Medtronic Melody valve | All patients that received a valve implantation were included in the registry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melody valve implantation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| time period before re-intervention on the valve |
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Inclusion Criteria:
Exclusion Criteria:
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all patients receiving a valve implantation, without exception (exhaustive population)
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| Name | Affiliation | Role |
|---|---|---|
| Sophie MALEKZADEH-MILANI, MD | Hôpital des enfants Malades - Necker, 149 rue de Sèvres, 75015 Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Louis Pradel | Bron | 69677 | France | |||
| Hôpital Gabriel Montpied |
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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 |
| patient characteristics | To compare the patient characteristics to the indications of the bioprosthesis | 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 | 60 months |
| failures of the implantation procedure | To document the failures of the implantation procedure | 60 months |
| survival rate at 12, 36, 48 and 60 months | To document the survival rate at 12, 36, 48 and 60 months | 60 months |
| frequency of antiplatelet treatment during and after implant | To describe the frequency of antiplatelet treatment during and after implant | 60 months |
| patients' characteristics to indications of the MELODY™ bioprosthesis | To compare patients' characteristics to indications of the MELODY™ bioprosthesis | 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 | 60 months |
| Clermont-Ferrand |
| 63003 |
| France |
| Centre chirurgical Marie Lannelongue | Le Plessis-Robinson | 92350 | France |
| Hôpital Cardiologique | Lille | 59037 | France |
| Hôpital de La Timone Enfants | Marseille | 13385 | France |
| Hôpital Laënnec | Nantes | 44800 | France |
| Hôpital des enfants Malades Necker | Paris | 75015 | France |
| Hôpital Cardiologique du Haut-Lévêque | Pessac | 33604 | France |
| Hôpital des enfants Purpan | Toulouse | 31059 | France |
| Clinique Pasteur | Toulouse | 31076 | France |