Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Right Ventricular Congenital Cardiopathies
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 409
- Locations
- 10
- Primary Endpoint
- absence of re-intervention on the pulmonary valve
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- rate re-intervention on the valve(60 months)
- patient characteristics(60 months)
- survival rate at 12, 36, 48 and 60 months(60 months)
- frequency of antiplatelet treatment during and after implant(60 months)
- Description and time of onset of open surgery after implantation(60 months)
- failures of the implantation procedure(60 months)
- patients' characteristics to indications of the MELODY™ bioprosthesis(60 months)
- time period before the resumption of professional, university or scholastic activity(60 months)
- time period before re-intervention on the valve(60 months)