Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation (FAST-TAVI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02404467|
Recruitment Status : Active, not recruiting
First Posted : March 31, 2015
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment|
|Aortic Stenosis||Device: TF TAVI|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|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|
Patients receiving tranfermoral TAVI
Device: TF TAVI
Follow-up Observation of patients having received a TF-TAVI
- 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.
- 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.
- Length-of-Stay after TAVI in days [ Time Frame: 1 year ]
- Relative costs of TAVI including hospitalization in either stratum compared to the LR / ED group [ Time Frame: 1 year ]
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
|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|
|AMC - Academic Medical Center - University of Amsterdam|
|Amsterdam, AZ, Netherlands, 1105|
|LUMC - Leiden University Medical Center|
|Leiden, Netherlands, 2333|
|Royal Vicotria Hospital, Belfast Trust|
|Belfast, United Kingdom, BT12 6BA|
|Cambridge, United Kingdom, CB23 3RE|
|James Cook Hospital|
|Middlesbrough, United Kingdom, TS4 3BW|
|Principal Investigator:||Corrado Tamburino, MD||Ferrarotto Hospital, University of Catania|
|Principal Investigator:||Marco Barbanti, MD||Ferrarotto Hospital, University of Catania|