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 transfemoral (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 transfermoral 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
October 2020