Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract
Pulmonary Valve Replacement : Study of Comparison Between a Standard Surgical Approach With Extracorporeal Circulation and an Off-pump Hybrid Strategy.
2 other identifiers
interventional
8
1 country
1
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 versus a medico-surgical hybrid strategy without extracorporeal circulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2005
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2005
CompletedFirst Posted
Study publicly available on registry
November 29, 2005
CompletedStudy Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedSeptember 30, 2009
March 1, 2007
3.4 years
November 28, 2005
September 29, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Right ventricular function
during the study
Secondary Outcomes (2)
Morbidity and mortality
during the study
Length of stay
during the study
Study Arms (2)
classic surgery
ACTIVE COMPARATORclassic surgery
medical surgery hybride
EXPERIMENTALmedical surgery hybride
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- Hôpital Necker-Enfants Maladescollaborator
- European Georges Pompidou Hospitalcollaborator
Study Sites (1)
NECKER HOSPITAL for Sick Children, 149 R. de SEVRES
Paris, 75015, France
Related Publications (1)
Boudjemline Y, Schievano S, Bonnet C, Coats L, Agnoletti G, Khambadkone S, Bonnet D, Deanfield J, Sidi D, Bonhoeffer P. Off-pump replacement of the pulmonary valve in large right ventricular outflow tracts: a hybrid approach. J Thorac Cardiovasc Surg. 2005 Apr;129(4):831-7. doi: 10.1016/j.jtcvs.2004.10.027.
PMID: 15821651BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Younes BOUDJEMLINE, MD,PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 28, 2005
First Posted
November 29, 2005
Study Start
December 1, 2005
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
September 30, 2009
Record last verified: 2007-03