Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract

Pulmonary Valve Insufficiency Clinical Trial

Official title:

Pulmonary Valve Replacement : Study of Comparison Between a Standard Surgical Approach With Extracorporeal Circulation and an Off-pump Hybrid Strategy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259207
• Other study ID #: P040413
• Secondary ID: AOR04068
• Status: Completed
• Phase: Phase 3
• First received: November 28, 2005
• Last updated: September 29, 2009
• Start date: December 2005
• Est. completion date: May 2009

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Procedure:
• Pulmonary valve insertion
Pulmonary valve insertion
• medical surgery hybride
medical surgery hybride

Locations

Country	Name	City	State
France	NECKER HOSPITAL for Sick Children, 149 R. de SEVRES	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	European Georges Pompidou Hospital, Hôpital Necker-Enfants Malades

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricular function		during the study	Yes
Secondary	Morbidity and mortality		during the study	Yes
Secondary	Length of stay		during the study	Yes