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

Study Overview
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Brief Summary
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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
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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

Official Title
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Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement for the Treatment of Lesions of the Ventricular Outflow Tract.

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

Intervention / Treatment
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* Device: Melody
* Device: bare stent
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melody<br>insertion of a pulmonic valved stent | Device: Melody<br>* insertion of a pulmonic valved stent<br>* Other names: insertion of a pulmonic valved stent;|
| Active Comparator: Bare stent<br>insertion of a bare metal stent | Device: bare stent<br>* insertion of a bare metal stent<br>* Other names: insertion of a bare metal stent;|
| Active Comparator: Surgery<br>conventional surgery methode. | Procedure: Surgery<br>* conventional surgery methode<br>* Other names: conventional surgery methode;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 24 months after intervention | 
| procedure success rate |  | 24 months after intervention | 
| Does the patient need to be operated again? |  | 24 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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right ventricular outflow tract, endovascular valve insertion, economic evaluation, valved stent