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

NCT02023775 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 409

Last updated 2025-07-03

No results posted yet for this study

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.

Conditions

  • Right Ventricular Congenital Cardiopathies

Interventions

DEVICE

Melody valve implantation

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Sophie MALEKZADEH-MILANI, MD · Hôpital des enfants Malades - Necker, 149 rue de Sèvres, 75015 Paris, France

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-01-24
Completion
2013-10-20

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02023775 on ClinicalTrials.gov