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

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Brief Title

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

Official Title

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

Brief 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.

Study Type

Observational [Patient Registry]

Primary Outcome

Feasibility and safety of early discharge after TF TAVI (cumulative incidence of death, hospitalization, complications)

Secondary Outcome

 Stratified Analysis of the cumulative incidence of a combination of the Primary outcome measures according to Patient risk factors and discharge date

Condition

Aortic Stenosis

Intervention

TF TAVI

Study Arms / Comparison Groups

 Patients receiving tranfermoral TAVI
Description:  TF TAVI

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

502

Start Date

January 2015

Completion Date

July 2019

Primary Completion Date

November 2018

Eligibility Criteria

        Inclusion Criteria:

          -  None

        Exclusion Criteria:

          -  None

          -  Beyond the applicable criteria of the IFU no further in- and exclusion criteria are
             defined.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Corrado Tamburino, MD, ,

Location Countries

Italy

Location Countries

Italy

Administrative Informations

NCT ID

NCT02404467

Organization ID

FAST-TAVI

Responsible Party

Sponsor

Study Sponsor

Institut für Pharmakologie und Präventive Medizin

Collaborators

 Edwards Lifesciences

Study Sponsor

Corrado Tamburino, MD, Principal Investigator, Ferrarotto Hospital, University of Catania

Verification Date

July 2019