Status:
COMPLETED
Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Hôpital Necker-Enfants Malades
European Georges Pompidou Hospital
Conditions:
Pulmonary Valve Insufficiency
Eligibility:
All Genders
6-90 years
Phase:
PHASE3
Brief 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...
Detailed Description
Pulmonary regurgitation is a common complication late after complete correction of a tetralogy of Fallot. It progressively leads to a right ventricular dilatation that has been strongly associated wit...
Eligibility Criteria
Inclusion
- Patient with surgical indication of pulmonary valve replacement for significant pulmonary regurgitation
- Pulmonary trunk diameter \> 22mm
- Age \> 5 years old or weight \> 20kg
- Acceptance of protocol
- Social regimen security
Exclusion
- No indication of pulmonary valve replacement
- Age \< 5 years old or weight \< 20kg
- Extra-cardiac disease with a vital prognosis under 6 months
- Heparin and contrast allergy
- Clinical or biological signs of infection
- Pregnancy
- Patients in emergency state
- Patients included in an another research protocol during the last months
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00259207
Start Date
December 1 2005
End Date
May 1 2009
Last Update
September 30 2009
Active Locations (1)
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1
NECKER HOSPITAL for Sick Children, 149 R. de SEVRES
Paris, France, 75015