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

Aortic Stenosis Clinical Trial

— FAST-TAVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02404467
• Other study ID #: FAST-TAVI
• Status: Completed
• Start date: January 2015
• Est. completion date: July 2019

Study information

• Verified date: October 2020
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: July 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• None

Exclusion Criteria:

• None

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Device:
• TF TAVI
Follow-up Observation of patients having received a TF-TAVI

Locations

Country	Name	City	State
Italy	Universita degli studi di Bari Aldo Moro	Bari
Italy	University Hospital of Bologna, Policlinico S. Orsola-Malpighi (Pad.23)	Bologna
Italy	Ferrarotto Hospital, University of Catania	Catania	Sicily
Italy	Montevergine Clinic	Mercogliano	AV
Italy	Clinica San Gaudenzio di Novara	Novara
Netherlands	AMC - Academic Medical Center - University of Amsterdam	Amsterdam	AZ
Netherlands	LUMC - Leiden University Medical Center	Leiden
United Kingdom	Royal Vicotria Hospital, Belfast Trust	Belfast
United Kingdom	Papworth Hospital	Cambridge
United Kingdom	James Cook Hospital	Middlesbrough

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin	Edwards Lifesciences

Countries where clinical trial is conducted

Italy,  Netherlands,  United Kingdom, 

References & Publications (3)

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, Lüske 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. — View 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: t — View 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, Lüske CM, Deutsch C, Kurucova J, Thoenes M, Bramlage P, Tamburino C, Barbanti M. Prespecified Risk — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and safety of early discharge after transfemoral (TF) TAVI (cumulative incidence of death, hospitalization, complications)	Cumulative incidence of a combination of all cause death, vascular Access related complications permanent Pacemaker Implantation, re-hospitalization due to cardiac reasons, and Major bleeding complications from day 4 to 30 after TAVI.	30 days after intervention
Secondary	Stratified Analysis of the cumulative incidence of a combination of the Primary outcome measures according to Patient risk factors and discharge date	Cumulative incidence of a combination of the primary outcome from day 4 to 30 in the LR / LD, HR / ED and HR / LD strata. Cumulative incidence of a combination of the primary outcome from day 4 to 15 in all strata.	30 days after intervention
Secondary	Length-of-Stay after TAVI in days		1 year
Secondary	Relative costs of TAVI including hospitalization in either stratum compared to the LR / ED group		1 year

External Links

•   registry on-line eCRF website