NCT02404467

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

3.8 years

First QC Date

March 23, 2015

Last Update Submit

October 21, 2020

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    30 days after intervention

  • Length-of-Stay after TAVI in days

    1 year

  • Relative costs of TAVI including hospitalization in either stratum compared to the LR / ED group

    1 year

Study Arms (1)

Patients receiving transfermoral TAVI

TF TAVI

Device: TF TAVI

Interventions

TF TAVIDEVICE

Follow-up Observation of patients having received a TF-TAVI

Patients receiving transfermoral TAVI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • None

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Montevergine Clinic

Mercogliano, AV, 83013, Italy

Location

Ferrarotto Hospital, University of Catania

Catania, Sicily, 95124, Italy

Location

Universita degli studi di Bari Aldo Moro

Bari, 70121, Italy

Location

University Hospital of Bologna, Policlinico S. Orsola-Malpighi (Pad.23)

Bologna, 40138, Italy

Location

Clinica San Gaudenzio di Novara

Novara, 28100, Italy

Location

AMC - Academic Medical Center - University of Amsterdam

Amsterdam, AZ, 1105, Netherlands

Location

LUMC - Leiden University Medical Center

Leiden, 2333, Netherlands

Location

Royal Vicotria Hospital, Belfast Trust

Belfast, BT12 6BA, United Kingdom

Location

Papworth Hospital

Cambridge, CB23 3RE, United Kingdom

Location

James Cook Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

Related 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, 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.

    PMID: 29017461BACKGROUND

  • 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.

    PMID: 30777842RESULT

  • 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.

    PMID: 32715844RESULT

Related Links

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Corrado Tamburino, MD

    Ferrarotto Hospital, University of Catania

    PRINCIPAL INVESTIGATOR

  • Marco Barbanti, MD

    Ferrarotto Hospital, University of Catania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 31, 2015

Study Start

January 1, 2015

Primary Completion

November 1, 2018

Study Completion

July 1, 2019

Last Updated

October 23, 2020

Record last verified: 2020-10

Locations

IT(5)GB(3)NL(2)