Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract

NCT ID: NCT00259207

Last Updated: 2009-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2009-05-31

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.

Conditions

Pulmonary Valve Insufficiency

Keywords

Pulmonary valve regurgitation; Valve replacement; Hybrid procedure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

classic surgery

classic surgery

Group Type: ACTIVE_COMPARATOR

Pulmonary valve insertion

Intervention Type: PROCEDURE

Pulmonary valve insertion

medical surgery hybride

medical surgery hybride

Group Type: EXPERIMENTAL

medical surgery hybride

Intervention Type: PROCEDURE

medical surgery hybride

Interventions

Pulmonary valve insertion

Pulmonary valve insertion

Intervention Type: PROCEDURE

medical surgery hybride

medical surgery hybride

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Necker-Enfants Malades

OTHER

Sponsor Role: collaborator

European Georges Pompidou Hospital

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Department Clinical Research of Developpement

Principal Investigators

Younes BOUDJEMLINE, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

NECKER HOSPITAL for Sick Children, 149 R. de SEVRES

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 15821651 (View on PubMed)

Other Identifiers

AOR04068

Identifier Type: -

Identifier Source: secondary_id

P040413

Identifier Type: -

Identifier Source: org_study_id