Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™ (Melody™FR)

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.

Study Overview

• Status: Completed
• Conditions: Right Ventricular Congenital Cardiopathies
• Intervention / Treatment: Device: Melody valve implantation

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.

• Study Type: Observational
• Enrollment (Actual): 409

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Hopital Louis Pradel
  • Clermont-Ferrand, France, 63003
    • Hôpital Gabriel Montpied
  • Le Plessis-Robinson, France, 92350
    • Centre chirurgical Marie Lannelongue
  • Lille, France, 59037
    • Hôpital Cardiologique
  • Marseille, France, 13385
    • Hôpital de la Timone Enfants
  • Nantes, France, 44800
    • Hôpital Laënnec
  • Paris, France, 75015
    • Hôpital des enfants Malades Necker
  • Pessac, France, 33604
    • Hôpital Cardiologique Du Haut-Lévêque
  • Toulouse, France, 31076
    • Clinique Pasteur
  • Toulouse, France, 31059
    • Hôpital des enfants Purpan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

all patients receiving a valve implantation, without exception (exhaustive population)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients implanted with Medtronic Melody valve; All patients that received a valve implantation were included in the registry.	Device: Melody valve implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Sophie MALEKZADEH-MILANI, MD, Hôpital des enfants Malades - Necker, 149 rue de Sèvres, 75015 Paris, France

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2010
• Primary Completion (Actual): January 24, 2013
• Study Completion (Actual): October 20, 2013

Study Registration Dates

• First Submitted: April 29, 2013
• First Submitted That Met QC Criteria: December 23, 2013
• First Posted (Estimated): December 30, 2013

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: Melody™ France