CompletedNot Applicable

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

France93 participantsStarted 2009-03

Plain-language 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).

Who can participate

Age range5 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT01250327

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-08

View on ClinicalTrials.gov More Dysfunction of the Prosthetic Conduct trials