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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Dysfunction of the Prosthetic Conduct; Lesions of the Right Ventricular Outflow Tract

Treatments: Device: bare stent; Procedure: Surgery; Device: Melody

Study type: Interventional

Funder types: Other

Identifiers

NCT01250327

P080205

Details and patient eligibility

About

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).

Full 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

Enrollment: 93 patients

Sex: All

Ages: 5 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 3 patient groups

Melody

Experimental group

Description:

insertion of a pulmonic valved stent

Treatment:

Device: Melody

Bare stent

Active Comparator group

Description:

insertion of a bare metal stent

Treatment:

Device: bare stent

Surgery

Active Comparator group

Description:

conventional surgery methode.

Treatment:

Procedure: Surgery