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.

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Valve Insufficiency
• Intervention / Treatment: Procedure: Pulmonary valve insertion; Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • NECKER HOSPITAL for Sick Children, 149 R. de SEVRES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: classic surgery	Procedure: Pulmonary valve insertion; Pulmonary valve insertion
Experimental: medical surgery hybride	Procedure: medical surgery hybride; medical surgery hybride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Right ventricular function	during the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Morbidity and mortality	during the study
Length of stay	during the study

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: European Georges Pompidou Hospital; Hôpital Necker-Enfants Malades
• Investigators: Principal Investigator: Younes BOUDJEMLINE, MD,PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: November 28, 2005
• First Submitted That Met QC Criteria: November 28, 2005
• First Posted (Estimate): November 29, 2005

Study Record Updates

• Last Update Posted (Estimate): September 30, 2009
• Last Update Submitted That Met QC Criteria: September 29, 2009
• Last Verified: March 1, 2007

More Information

Terms related to this study

• Keywords: Valve replacement; Pulmonary valve regurgitation; Hybrid procedure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Pulmonary Valve Insufficiency
• Other Study ID Numbers: P040413; AOR04068