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Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259207
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : September 30, 2009
Hôpital Necker-Enfants Malades
European Georges Pompidou Hospital
Information provided by:
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Pulmonary Valve Insufficiency Procedure: Pulmonary valve insertion Procedure: medical surgery hybride Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pulmonary Valve Replacement : Study of Comparison Between a Standard Surgical Approach With Extracorporeal Circulation and an Off-pump Hybrid Strategy.
Study Start Date : December 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Active Comparator: classic surgery
classic surgery
Procedure: Pulmonary valve insertion
Pulmonary valve insertion

Experimental: medical surgery hybride
medical surgery hybride
Procedure: medical surgery hybride
medical surgery hybride

Primary Outcome Measures :
  1. Right ventricular function [ Time Frame: during the study ]

Secondary Outcome Measures :
  1. Morbidity and mortality [ Time Frame: during the study ]
  2. Length of stay [ Time Frame: during the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259207

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NECKER HOSPITAL for Sick Children, 149 R. de SEVRES
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Hôpital Necker-Enfants Malades
European Georges Pompidou Hospital
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Principal Investigator: Younes BOUDJEMLINE, MD,PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Cecile Jourdain, Department Clinical Research of Developpement Identifier: NCT00259207    
Other Study ID Numbers: P040413
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: September 30, 2009
Last Verified: March 2007
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pulmonary valve regurgitation
Valve replacement
Hybrid procedure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases