Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation
NCT ID: NCT02404467
Last Updated: 2020-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
502 participants
OBSERVATIONAL
2015-01-31
2019-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Patients receiving transfermoral TAVI
TF TAVI
TF TAVI
Follow-up Observation of patients having received a TF-TAVI
Interventions
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TF TAVI
Follow-up Observation of patients having received a TF-TAVI
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Institut für Pharmakologie und Präventive Medizin
NETWORK
Responsible Party
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Principal Investigators
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Corrado Tamburino, MD
Role: PRINCIPAL_INVESTIGATOR
Ferrarotto Hospital, University of Catania
Marco Barbanti, MD
Role: PRINCIPAL_INVESTIGATOR
Ferrarotto Hospital, University of Catania
Locations
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Montevergine Clinic
Mercogliano, AV, Italy
Ferrarotto Hospital, University of Catania
Catania, Sicily, Italy
Universita degli studi di Bari Aldo Moro
Bari, , Italy
University Hospital of Bologna, Policlinico S. Orsola-Malpighi (Pad.23)
Bologna, , Italy
Clinica San Gaudenzio di Novara
Novara, , Italy
AMC - Academic Medical Center - University of Amsterdam
Amsterdam, AZ, Netherlands
LUMC - Leiden University Medical Center
Leiden, , Netherlands
Royal Vicotria Hospital, Belfast Trust
Belfast, , United Kingdom
Papworth Hospital
Cambridge, , United Kingdom
James Cook Hospital
Middlesbrough, , United Kingdom
Countries
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References
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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.
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.
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.
Related Links
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registry on-line eCRF website
Other Identifiers
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FAST-TAVI
Identifier Type: -
Identifier Source: org_study_id
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