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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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).
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melody | Experimental | insertion of a pulmonic valved stent |
|
| Bare stent | Active Comparator | insertion of a bare metal stent |
|
| Surgery | Active Comparator | conventional surgery methode. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melody | Device | insertion of a pulmonic valved stent |
|
|
| 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 |
| 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? |
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Inclusion Criteria:
for the study:
for the Melody arm:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boudjemline Younes, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Necker Enfants Malades | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25453718 | Derived | Fraisse A, Aldebert P, Malekzadeh-Milani S, Thambo JB, Piechaud JF, Aucoururier P, Chatelier G, Bonnet D, Iserin L, Bonello B, Assaidi A, Kammache I, Boudjemline Y. Melody (R) transcatheter pulmonary valve implantation: results from a French registry. Arch Cardiovasc Dis. 2014 Nov;107(11):607-14. doi: 10.1016/j.acvd.2014.10.001. Epub 2014 Nov 6. |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| bare stent | Device | insertion of a bare metal stent |
|
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| Surgery | Procedure | conventional surgery methode |
|
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| 24 months after intervention |