Status:
COMPLETED
Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Dysfunction of the Prosthetic Conduct
Lesions of the Right Ventricular Outflow Tract
Eligibility:
All Genders
5-70 years
Phase:
NA
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 (Me...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT01250327
Start Date
March 1 2009
End Date
August 1 2013
Last Update
October 18 2017
Active Locations (1)
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1
Hôpital Necker Enfants Malades
Paris, France, 75015