Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement for the Treatment of Lesions of the Ventricular Outflow Tract.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dysfunction of the Prosthetic Conduct
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Cost induced by the transcatheter pulmonary valve insertion as compared to conventional surgical and insertion of a bare metal stent 24 months after insertion.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
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
Outcomes
Primary Outcomes
Cost induced by the transcatheter pulmonary valve insertion as compared to conventional surgical and insertion of a bare metal stent 24 months after insertion.
Time Frame: 24 months after intervention
Secondary Outcomes
- Quality of life(24 months after intervention)
- Does the patient need to be operated again?(24 months after intervention)
- procedure success rate(24 months after intervention)