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Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation — FAST-TAVI  

Aortic Stenosis Clinical Trial

Official title:
Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation The FAST-TAVI Study

Clinical Trial Summary

The hypothesis behind this study is that there is a proportion of patients considered high or intermediate risk for surgery, but relatively low risk for TAVI, which can be discharged early after the procedure (within the first 2-3 days) without additional risks. Therefore, when performed in safety, an early discharge may cut periprocedural TAVI costs significantly.

Clinical Trial Description

TAVI (Transcatheter aortic valve Implantation) - A viable alternative to surgical aortic valve replacement for patients with severe symptomatic aortic stenosis. Considered as being at unacceptable surgical risk. Despite its widespread utilization, there are procedure specific complications and hospitalization associated costs that limit TAVI expansion into patient populations with lower risk. Cost-effectiveness of TAVI has been investigated either compared with standard therapy for patients who are not candidates for surgical valve replacement or with conventional surgical replacement in high-risk patients. Formal economic evaluation in inoperable patients demonstrated that the benefits of TAVI were achieved at an acceptable incremental cost to society, at least in the context of the U.S. and U.K. health systems. In patients with severe, symptomatic AS who are at high but not prohibitive surgical risk, the PARTNER A trial demonstrated that TAVI appeared to be an economically attractive strategy compared with aortic valve replacement, provided that patients are suitable for a transfemoral approach. On the other hand, results for trans-apical TAVI compared with surgical replacement were economically unfavorable. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02404467
Study type Observational [Patient Registry]
Source Institut für Pharmakologie und Präventive Medizin
Contact
Status Completed
Phase
Start date January 2015
Completion date July 2019
View Details
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