Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™
- Conditions
- Right Ventricular Congenital Cardiopathies
- Interventions
- Device: Melody valve implantation
- Registration Number
- NCT02023775
- Lead Sponsor
- Medtronic Bakken Research Center
- Brief 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 409
- Patients requiring pulmonary valvular replacement for correction of right ventricular ejection path malfunction (stenosis and/or pulmonary regurgitation).
- Patient or legal representative refusal to data collection or processing
- Patient unable to guarantee follow-up data collection, in particular for patients living abroad
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients implanted with Medtronic Melody valve Melody valve implantation All patients that received a valve implantation were included in the registry.
- Primary Outcome Measures
Name Time Method absence of re-intervention on the pulmonary valve 12 months to evaluate the efficacy of the MELODY valve, defined as the absence of re-intervention on the pulmonary valvee
- Secondary Outcome Measures
Name Time Method rate re-intervention on the valve 60 months To document the rate re-intervention on the valve during a 60 months follow-up after its implantation
patient characteristics 60 months To compare the patient characteristics to the indications of the bioprosthesis
survival rate at 12, 36, 48 and 60 months 60 months To document the survival rate at 12, 36, 48 and 60 months
frequency of antiplatelet treatment during and after implant 60 months To describe the frequency of antiplatelet treatment during and after implant
Description and time of onset of open surgery after implantation 60 months Description and time of onset of open surgery after implantation on first implanted patients versus device replacement
patients' characteristics to indications of the MELODY™ bioprosthesis 60 months To compare patients' characteristics to indications of the MELODY™ bioprosthesis
time period before the resumption of professional, university or scholastic activity 60 months To document the time period before the resumption of professional, university or scholastic activity
time period before re-intervention on the valve 60 months 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)
failures of the implantation procedure 60 months To document the failures of the implantation procedure
Trial Locations
- Locations (10)
Hôpital Louis Pradel
🇫🇷Bron, France
Hôpital Gabriel Montpied
🇫🇷Clermont-Ferrand, France
Centre chirurgical Marie Lannelongue
🇫🇷Le Plessis-Robinson, France
Hôpital Laënnec
🇫🇷Nantes, France
Hôpital de La Timone Enfants
🇫🇷Marseille, France
Hôpital des enfants Malades Necker
🇫🇷Paris, France
Hôpital Cardiologique du Haut-Lévêque
🇫🇷Pessac, France
Hôpital des enfants Purpan
🇫🇷Toulouse, France
Clinique Pasteur
🇫🇷Toulouse, France
Hôpital Cardiologique
🇫🇷Lille, France