Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-03-11 @ 4:30 PM
Study NCT ID:
NCT01250327
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2010-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement for the Treatment of Lesions of the Ventricular Outflow Tract.
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVALV
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: