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SAfe and Fast Discharge With Acurate Valve in Low Risk tavI Patients
Sponsor: Maria Cecilia Hospital
Summary
Recent evidence from scientific literature supported the extension of TAVI procedures to lower risk populations. Despite its widespread usage, the expansion of TAVI into lower risk patient populations is still limited by complications and costs, with a large disparity between clinical trials and real-world scenarios suggesting still long hospitalizations after TAVI. This issue has got relevant implications in cost-effectiveness of the procedure, with many studies showing a more favourable cost profile associated with early discharges
Official title: Safe and Fast Discharge With Acurate Valve in Low Risk Tavi Patients
Key Details
Gender
All
Age Range
18 Years - 83 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2022-09-26
Completion Date
2025-12
Last Updated
2024-09-19
Healthy Volunteers
No
Conditions
Interventions
Transaortic valve replacement
TAVI procedure will be performed under conscious sedation. Foley urinary catheters and jugular lines will be avoided. For femoral access, closure devices will be Prostar or ProGlide, which are similar and carry low rates of major vascular complications . Single femoral access and a radial access as the secondary arterial access will be used to reduce the rate of vascular complications. All procedures will be performed with cerebral protection using the Sentinel device. During valve implantation, commissural alignment will be checked for all patients. As a practical rule, commissural alignment will be checked in co-planar view and in cusp-overlap view.
Locations (1)
Maria Cecilia Hospital
Cotignola, Ravenna, Italy