Clinical trial NCT02404467: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
Collaborators: name: Edwards Lifesciences
First posted: 2015-03-31
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 500 consecutive patients with severe aortic stenosis selected for TF TAVI at the respective site will be enrolled. Beyond the applicable criteria of the IFU no further in- and exclusion criteria are defined.

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.

Eligibility criteria: Inclusion Criteria:

* None

Exclusion Criteria:

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

Primary outcomes:
measure: Feasibility and safety of early discharge after transfemoral (TF) TAVI (cumulative incidence of death, hospitalization, complications)
timeFrame: 30 days after intervention
Secondary outcomes:
measure: Stratified Analysis of the cumulative incidence of a combination of the Primary outcome measures according to Patient risk factors and discharge date
timeFrame: 30 days after intervention
measure: Length-of-Stay after TAVI in days
timeFrame: 1 year
measure: Relative costs of TAVI including hospitalization in either stratum compared to the LR / ED group
timeFrame: 1 year
Other outcomes:
Locations:
city: Mercogliano
country: Italy
facility: Montevergine Clinic
state: AV
city: Catania
country: Italy
facility: Ferrarotto Hospital, University of Catania
state: Sicily
city: Bari
country: Italy
facility: Universita degli studi di Bari Aldo Moro
city: Bologna
country: Italy
facility: University Hospital of Bologna, Policlinico S. Orsola-Malpighi (Pad.23)
city: Novara
country: Italy
facility: Clinica San Gaudenzio di Novara
city: Amsterdam
country: Netherlands
facility: AMC - Academic Medical Center - University of Amsterdam
state: AZ
city: Leiden
country: Netherlands
facility: LUMC - Leiden University Medical Center
city: Belfast
country: United Kingdom
facility: Royal Vicotria Hospital, Belfast Trust
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook Hospital
Study officials:
affiliation: Ferrarotto Hospital, University of Catania
name: Corrado Tamburino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ferrarotto Hospital, University of Catania
name: Marco Barbanti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barbanti M, Baan J, Spence MS, Iacovelli F, Martinelli GL, Saia F, Bortone AS, van der Kley F, Muir DF, Densem CG, Vis M, van Mourik MS, Seilerova L, Luske CM, Bramlage P, Tamburino C. Feasibility and safety of early discharge after transfemoral transcatheter aortic valve implantation - rationale and design of the FAST-TAVI registry. BMC Cardiovasc Disord. 2017 Oct 10;17(1):259. doi: 10.1186/s12872-017-0693-0.
citation: Barbanti M, van Mourik MS, Spence MS, Iacovelli F, Martinelli GL, Muir DF, Saia F, Bortone AS, Densem CG, van der Kley F, Bramlage P, Vis M, Tamburino C. Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: the multicentre European FAST-TAVI trial. EuroIntervention. 2019 Jun 20;15(2):147-154. doi: 10.4244/EIJ-D-18-01197.
citation: Spence MS, Baan J, Iacovelli F, Martinelli GL, Muir DF, Saia F, Bortone AS, Densem CG, Owens CG, van der Kley F, Vis M, van Mourik MS, Costa G, Sykorova L, Luske CM, Deutsch C, Kurucova J, Thoenes M, Bramlage P, Tamburino C, Barbanti M. Prespecified Risk Criteria Facilitate Adequate Discharge and Long-Term Outcomes After Transfemoral Transcatheter Aortic Valve Implantation. J Am Heart Assoc. 2020 Aug 4;9(15):e016990. doi: 10.1161/JAHA.120.016990. Epub 2020 Jul 25.