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

I

Institut für Pharmakologie und Präventive Medizin

Status

Completed

Conditions

Aortic Stenosis

Treatments

Device: TF TAVI

Study type

Observational

Funder types

NETWORK
Industry

Identifiers

NCT02404467
FAST-TAVI

Details and patient eligibility

About

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.

Full 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.

Enrollment

502 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • None

Exclusion criteria

  • None
  • Beyond the applicable criteria of the IFU no further in- and exclusion criteria are defined.

Trial design

502 participants in 1 patient group

Patients receiving transfermoral TAVI
Description:
TF TAVI
Treatment:
Device: TF TAVI

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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