Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™

N/ACompletedNCT02023775

Medtronic Cardiac Rhythm and Heart Failure409 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

409

Conditions

Right Ventricular Congenital Cardiopathies

Interventions

Melody valve implantationDEVICE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (10)

Hôpital Louis Pradel

Bron, France

Hôpital Gabriel Montpied

Clermont-Ferrand, France

Centre chirurgical Marie Lannelongue

Le Plessis-Robinson, France

Hôpital Cardiologique

Lille, France

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

rate re-intervention on the valve

To document the rate re-intervention on the valve during a 60 months follow-up after its implantation

Time frame: 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)

Time frame: 60 months

patient characteristics

To compare the patient characteristics to the indications of the bioprosthesis

Time frame: 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

Time frame: 60 months

failures of the implantation procedure

To document the failures of the implantation procedure

Time frame: 60 months

survival rate at 12, 36, 48 and 60 months

To document the survival rate at 12, 36, 48 and 60 months

Time frame: 60 months

Data from ClinicalTrials.gov

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