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Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation (FAST-TAVI)

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ClinicalTrials.gov Identifier: NCT02404467
Recruitment Status : Active, not recruiting
First Posted : March 31, 2015
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

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.

Condition or disease Intervention/treatment
Aortic Stenosis Device: TF TAVI

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation The FAST-TAVI Study
Actual Study Start Date : January 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients receiving tranfermoral TAVI
TF TAVI
Device: TF TAVI
Follow-up Observation of patients having received a TF-TAVI




Primary Outcome Measures :
  1. Feasibility and safety of early discharge after TF TAVI (cumulative incidence of death, hospitalization, complications) [ Time Frame: 30 days after intervention ]
    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.


Secondary Outcome Measures :
  1. Stratified Analysis of the cumulative incidence of a combination of the Primary outcome measures according to Patient risk factors and discharge date [ Time Frame: 30 days after intervention ]
    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.

  2. Length-of-Stay after TAVI in days [ Time Frame: 1 year ]
  3. Relative costs of TAVI including hospitalization in either stratum compared to the LR / ED group [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • None

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404467


Locations
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Italy
Montevergine Clinic
Mercogliano, AV, Italy, 83013
Ferrarotto Hospital, University of Catania
Catania, Sicily, Italy, 95124
Universita degli studi di Bari Aldo Moro
Bari, Italy, 70121
University Hospital of Bologna, Policlinico S. Orsola-Malpighi (Pad.23)
Bologna, Italy, 40138
Clinica San Gaudenzio di Novara
Novara, Italy, 28100
Netherlands
AMC - Academic Medical Center - University of Amsterdam
Amsterdam, AZ, Netherlands, 1105
LUMC - Leiden University Medical Center
Leiden, Netherlands, 2333
United Kingdom
Royal Vicotria Hospital, Belfast Trust
Belfast, United Kingdom, BT12 6BA
Papworth Hospital
Cambridge, United Kingdom, CB23 3RE
James Cook Hospital
Middlesbrough, United Kingdom, TS4 3BW
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Edwards Lifesciences
Investigators
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Principal Investigator: Corrado Tamburino, MD Ferrarotto Hospital, University of Catania
Principal Investigator: Marco Barbanti, MD Ferrarotto Hospital, University of Catania

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT02404467     History of Changes
Other Study ID Numbers: FAST-TAVI
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction