Clinical trial NCT01250327: Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)
Official title: Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement for the Treatment of Lesions of the Ventricular Outflow Tract.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysfunction of the Prosthetic Conduct
Lesions of the Right Ventricular Outflow Tract
Keywords: right ventricular outflow tract
endovascular valve insertion
economic evaluation
valved stent
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2010-11-30
Enrollment: 93
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Cost induced by the transcatheter pulmonary valve insertion as compared to conventional surgical and insertion of a bare metal stent 24 months after insertion.
timeFrame: 24 months after intervention
Secondary outcomes:
measure: Quality of life
timeFrame: 24 months after intervention
measure: procedure success rate
timeFrame: 24 months after intervention
measure: Does the patient need to be operated again?
timeFrame: 24 months after intervention
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Boudjemline Younes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.