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Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)

NCT01250327 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2017-10-18

No results posted yet for this study

Summary

This prospective interventional study is designed to evaluate the cost/advantage ratio in the treatment of lesions of the right ventricular outflow tract using transcatheter pulmonary valved stent (Melody).

Conditions

  • Dysfunction of the Prosthetic Conduct
  • Lesions of the Right Ventricular Outflow Tract

Interventions

DEVICE

Melody

insertion of a pulmonic valved stent

DEVICE

bare stent

insertion of a bare metal stent

PROCEDURE

Surgery

conventional surgery methode

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Boudjemline Younes, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-08-31
Completion
2013-08-31

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 NCT01250327 on ClinicalTrials.gov