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

Assistance Publique - Hôpitaux de Paris93 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dysfunction of the Prosthetic Conduct Lesions of the Right Ventricular Outflow Tract

Interventions

MelodyDEVICE

insertion of a pulmonic valved stent

bare stentDEVICE

insertion of a bare metal stent

SurgeryPROCEDURE

conventional surgery methode

Eligibility

Sex: ALLMin age: 5 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Necker Enfants Malades

Paris, France

Outcomes

Primary Outcomes

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

Time frame: 24 months after intervention

Secondary Outcomes

Quality of life

Time frame: 24 months after intervention

procedure success rate

Time frame: 24 months after intervention

Does the patient need to be operated again?

Time frame: 24 months after intervention

Data from ClinicalTrials.gov

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