Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation
- Conditions
- Aortic Stenosis
- Interventions
- Device: TF TAVI
- Registration Number
- NCT02404467
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 502
- None
- None
- Beyond the applicable criteria of the IFU no further in- and exclusion criteria are defined.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients receiving transfermoral TAVI TF TAVI TF TAVI
- Primary Outcome Measures
Name Time Method Feasibility and safety of early discharge after transfemoral (TF) TAVI (cumulative incidence of death, hospitalization, complications) 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
Name Time Method Relative costs of TAVI including hospitalization in either stratum compared to the LR / ED group 1 year 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 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 1 year
Trial Locations
- Locations (10)
LUMC - Leiden University Medical Center
🇳🇱Leiden, Netherlands
Ferrarotto Hospital, University of Catania
🇮🇹Catania, Sicily, Italy
AMC - Academic Medical Center - University of Amsterdam
🇳🇱Amsterdam, AZ, Netherlands
Montevergine Clinic
🇮🇹Mercogliano, AV, 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
Royal Vicotria Hospital, Belfast Trust
🇬🇧Belfast, United Kingdom
James Cook Hospital
🇬🇧Middlesbrough, United Kingdom
Papworth Hospital
🇬🇧Cambridge, United Kingdom