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Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract

NCT00259207 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2009-09-30

No results posted yet for this study

Summary

The purpose of this study is to compare 2 techniques of pulmonary valve replacement in patients with a large right ventricular outflow tract: a standard surgical treatment using cardiopulmonary bypass versus a medico-surgical hybrid strategy without extracorporeal circulation.

Conditions

  • Pulmonary Valve Insufficiency

Interventions

PROCEDURE

Pulmonary valve insertion

Pulmonary valve insertion

PROCEDURE

medical surgery hybride

medical surgery hybride

Sponsors & Collaborators

  • Hôpital Necker-Enfants Malades

    collaborator OTHER

  • European Georges Pompidou Hospital

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2009-05-31
Completion
2009-05-31

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 NCT00259207 on ClinicalTrials.gov