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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00259207 |
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Date of registration:
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28/11/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract
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Scientific title:
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Pulmonary Valve Replacement : Study of Comparison Between a Standard Surgical Approach With Extracorporeal Circulation and an Off-pump Hybrid Strategy. |
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Date of first enrolment:
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December 2005 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00259207 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Younes BOUDJEMLINE, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patient with surgical indication of pulmonary valve replacement for significant
pulmonary regurgitation
2. Pulmonary trunk diameter > 22mm
3. Age > 5 years old or weight > 20kg
4. Acceptance of protocol
5. Social regimen security
Exclusion Criteria:
1. No indication of pulmonary valve replacement
2. Age < 5 years old or weight < 20kg
3. Extra-cardiac disease with a vital prognosis under 6 months
4. Heparin and contrast allergy
5. Clinical or biological signs of infection
6. Pregnancy
7. Patients in emergency state
8. Patients included in an another research protocol during the last months
Age minimum:
6 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Valve Insufficiency
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Intervention(s)
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Procedure: Pulmonary valve insertion
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Procedure: medical surgery hybride
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Primary Outcome(s)
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Right ventricular function
[Time Frame: during the study]
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Secondary Outcome(s)
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Length of stay
[Time Frame: during the study]
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Morbidity and mortality
[Time Frame: during the study]
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Secondary ID(s)
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AOR04068
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P040413
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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