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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

409 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-10-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Right Ventricular Congenital Cardiopathies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients implanted with Medtronic Melody valve

All patients that received a valve implantation were included in the registry.

Melody valve implantation

Intervention Type DEVICE

Interventions

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Melody valve implantation

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No