Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract

This study has been completed.
Sponsor:
Collaborators:
Hôpital Necker-Enfants Malades
European Georges Pompidou Hospital
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00259207
First received: November 28, 2005
Last updated: September 29, 2009
Last verified: March 2007
  Purpose

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 Intervention Phase
Pulmonary Valve Insufficiency
Procedure: Pulmonary valve insertion
Procedure: medical surgery hybride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Right ventricular function [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Morbidity and mortality [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • Length of stay [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: December 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: classic surgery
classic surgery
Procedure: Pulmonary valve insertion
Pulmonary valve insertion
Other Name: Pulmonary valve insertion
Experimental: medical surgery hybride
medical surgery hybride
Procedure: medical surgery hybride
medical surgery hybride
Other Name: medical surgery hybride

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.

  Eligibility

Ages Eligible for Study:   6 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00259207

Locations
France
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
Investigators
Principal Investigator: Younes BOUDJEMLINE, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Cecile Jourdain, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00259207     History of Changes
Other Study ID Numbers: P040413, AOR04068
Study First Received: November 28, 2005
Last Updated: September 29, 2009
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pulmonary valve regurgitation
Valve replacement
Hybrid procedure

Additional relevant MeSH terms:
Pulmonary Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014