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

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Medtronic

Status

Completed

Conditions

Right Ventricular Congenital Cardiopathies

Treatments

Device: Melody valve implantation

Study type

Observational

Funder types

Industry

Identifiers

NCT02023775
Melody™ France

Details and patient eligibility

About

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.

Full 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.

Enrollment

409 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

409 participants in 1 patient group

Patients implanted with Medtronic Melody valve
Description:
All patients that received a valve implantation were included in the registry.
Treatment:
Device: Melody valve implantation

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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