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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01250327

Acronym

REVALV

Enrollment

Registered

2010-11-30

Start date

2009-03-31

Completion date

2013-08-31

Last updated

2017-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

Interventions

DEVICEMelody

insertion of a pulmonic valved stent

DEVICEbare stent

insertion of a bare metal stent

PROCEDURESurgery

conventional surgery methode

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 70 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026