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Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract

Primary Purpose

Pulmonary Valve Insufficiency

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Pulmonary valve insertion
medical surgery hybride
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Valve Insufficiency focused on measuring Pulmonary valve regurgitation, Valve replacement, Hybrid procedure

Eligibility Criteria

6 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

  • NECKER HOSPITAL for Sick Children, 149 R. de SEVRES

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

classic surgery

medical surgery hybride

Arm Description

classic surgery

medical surgery hybride

Outcomes

Primary Outcome Measures

Right ventricular function

Secondary Outcome Measures

Morbidity and mortality
Length of stay

Full Information

First Posted
November 28, 2005
Last Updated
September 29, 2009
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Hôpital Necker-Enfants Malades, European Georges Pompidou Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00259207
Brief Title
Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract
Official Title
Pulmonary Valve Replacement : Study of Comparison Between a Standard Surgical Approach With Extracorporeal Circulation and an Off-pump Hybrid Strategy.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Hôpital Necker-Enfants Malades, European Georges Pompidou Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 with ventricular arrhythmia, sudden death and right ventricular insufficiency. Pulmonary valve replacement reduces the rate of complications but the precise timing for this procedure remains unknown. Moreover, pulmonary valve replacement, even before the occurrence of symptoms, doesn't allow for a total recovery in all patients. Reasons are not known, but cardiopulmonary bypass as well as late referral to surgery have been incriminated to explain the persistence of right ventricular dysfunction after surgical valvular. Therefore, a strategy avoiding cardiopulmonary bypass could potentially preserve the right ventricular function and in the meantime reduce the hospitalisation length and morbid-mortality. For the last six years, we and others have developed a technique of percutaneous pulmonary valve implantation. Encouraging results were reported in the treatment of failing right ventricular to pulmonary artery conduit, but presents indications are limited and the innovative technique could not be offered to most of patients requiring pulmonary valve replacement. In particular, to date, conventional surgery is the only approach for patients with large pulmonary trunk over 22 mm in diameter. We had the idea of collaborating with the surgeons to try to improve the outcome of valvular in these patients. We would like to investigate a hybrid strategy in those patients with large right ventricular outflow tract inaccessible to solely transcatheter technique. The studied technique will associate a surgical pulmonary artery banding without cardiopulmonary bypass immediately followed by a transventricular or a transvenous pulmonary valve insertion using a conventional valved stent. The purpose of this randomized study is to evaluate benefits and risks of the medico-surgical hybrid strategy, and to compare both strategies hybrid approach and conventional surgery with extracorporeal circulation in term of right ventricular function recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Valve Insufficiency
Keywords
Pulmonary valve regurgitation, Valve replacement, Hybrid procedure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
classic surgery
Arm Type
Active Comparator
Arm Description
classic surgery
Arm Title
medical surgery hybride
Arm Type
Experimental
Arm Description
medical surgery hybride
Intervention Type
Procedure
Intervention Name(s)
Pulmonary valve insertion
Intervention Description
Pulmonary valve insertion
Intervention Type
Procedure
Intervention Name(s)
medical surgery hybride
Intervention Description
medical surgery hybride
Primary Outcome Measure Information:
Title
Right ventricular function
Time Frame
during the study
Secondary Outcome Measure Information:
Title
Morbidity and mortality
Time Frame
during the study
Title
Length of stay
Time Frame
during the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Younes BOUDJEMLINE, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
NECKER HOSPITAL for Sick Children, 149 R. de SEVRES
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15821651
Citation
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.
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Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract

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