NCT02404467

Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 502 (actual)
• Sponsor: Institut für Pharmakologie und Präventive Medizin · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	TF TAVI	Follow-up Observation of patients having received a TF-TAVI

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-11-01
• Completion: 2019-07-01
• First posted: 2015-03-31
• Last updated: 2020-10-23

Locations

10 sites across 3 countries: Italy, Netherlands, United Kingdom