Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)

Not Applicable

Completed

• Conditions: Dysfunction of the Prosthetic Conduct; Lesions of the Right Ventricular Outflow Tract
• Interventions: Device: Melody; Device: bare stent; Procedure: Surgery

• Registration Number: NCT01250327
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

This prospective interventional study is designed to evaluate the cost/advantage ratio in the treatment of lesions of the right ventricular outflow tract using transcatheter pulmonary valved stent (Melody).

Detailed Description

Rational : transcatheter valve insertion is a new technique enlarging the armamentarium of the treatment of RVOT obstruction and insufficiency. It real place as compared to bare stent implantation and surgery of the RVOT remains unknown.

Main objective : evaluate the cost of the procedure as compared with conventional technique.

Design : multicenter intervention prospective study. Population : 180 patients in three arms (3\*60).

End point criteria :

* Primary : cost

* Secondary : rate of reoperation

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-11-27
• Study First Submitted QC: 2010-11-29
• Study First Posted: 2010-11-30
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

for the study:

• Lesions of the right ventricular outflow tract in need of surgery for stenosis or regurgitation

for the Melody arm:

• A 5 to 70 years old patient
• Weight >= 30kg
• RVOT <= to 22mm
• Patient with a dysfunction circumferential prosthetic conduct of diameter >= to 16mm.

Exclusion Criteria

• Vein anatomy incompatibility with a 22Fr delivery health
• Left heart implantation
• RVOT incompatible with a anchoring of the stent (lik in patient operated of a tetralogy of fallot)
• Coronary anomaly with a coronary artery naer the RVOT
• Sever obstruction of the RVOT incompatible with balloon expansion
• Central vein obstruction
• Ongoing infection
• Active endocarditis
• Allergy for heparin or aspirin
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melody	Melody	insertion of a pulmonic valved stent
Bare stent	bare stent	insertion of a bare metal stent
Surgery	Surgery	conventional surgery methode.

Primary Outcome Measures

Name	Time	Method
Cost induced by the transcatheter pulmonary valve insertion as compared to conventional surgical and insertion of a bare metal stent 24 months after insertion.	24 months after intervention

Secondary Outcome Measures

Name	Time	Method
Quality of life	24 months after intervention
Does the patient need to be operated again?	24 months after intervention
procedure success rate	24 months after intervention

Trial Locations

Locations (1)

Hôpital Necker Enfants Malades; 🇫🇷 Paris, France