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Completed

NCT Number: NCT02023775

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

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.

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Key information

Conditions

Right Ventricular Congenital Cardiopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Louis Pradel, Bron, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melody valve implantation

Device

Primary outcomes

  1. 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

  1. rate re-intervention on the valve

    Time frame: 60 months

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

  2. time period before re-intervention on the valve

    Time frame: 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)

  3. patient characteristics

    Time frame: 60 months

    To compare the patient characteristics to the indications of the bioprosthesis

  4. Description and time of onset of open surgery after implantation

    Time frame: 60 months

    Description and time of onset of open surgery after implantation on first implanted patients versus device replacement

  5. failures of the implantation procedure

    Time frame: 60 months

    To document the failures of the implantation procedure

  6. survival rate at 12, 36, 48 and 60 months

    Time frame: 60 months

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

  7. frequency of antiplatelet treatment during and after implant

    Time frame: 60 months

    To describe the frequency of antiplatelet treatment during and after implant

  8. patients' characteristics to indications of the MELODY™ bioprosthesis

    Time frame: 60 months

    To compare patients' characteristics to indications of the MELODY™ bioprosthesis

  9. time period before the resumption of professional, university or scholastic activity

    Time frame: 60 months

    To document the time period before the resumption of professional, university or scholastic activity

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Acronym: Melody™FR

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 30, 2013
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.