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

Study of Transcatheter Pulmonary Valve Replacement in France

Recruiting
1 years - 100 years
All
Phase N/A
2 Locations

Brief description of study

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 of 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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Right Ventricular Congenital Cardiopathies
  • Age: 1 years - 100 years
  • Gender: All

Inclusion Criteria:

  •  

Exclusion Criteria:

  •  

The purpose of this research study is to collect information over time on pulmonary valve replacement done through a catheter (a thin tube) using a bioprosthetic valve in France. The study was requested by French health authorities to support renewal of reimbursement for this procedure when used for approved medical reasons in France.

Participants will be included in a national registry that records implantations done during a set time period. The study observes what happens after the valve replacement procedure and does not compare different treatments. The study was closed in 2013.

Who can participate:
People who have pulmonary valve replacement by bioprosthesis in an approved indication in France may be able to participate if they:

  • Have this valve replacement procedure during the registry’s enrollment period in France

Updated on 27 Jul 2026. Study ID: IRB-098786

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