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Transcatheter AortiC Valve Implantation in AorTic StenosIs CardiogenIc Shock
Sponsor: Rigshospitalet, Denmark
Summary
The goal of this clinical trial is to learn if acute transcatheter aortic valve implantation (TAVI) is superior to standard treatment (stabilization in an intensive care unit and TAVI subsequently) to treat cardiogenic shock in patients with critical severe aortic stenosis. The main questions it aims to answer are: • Does acute TAVI increase survival compared with standard treatment? Participants will: * Undergo either TAVI within 12 hours after admission or stabilization and TAVI 72 hours or more after admission * Visit an outpatient clinic and be evaluated for quality of life and heart function
Official title: Transcatheter AortiC Valve Implantation in AorTic StenosIs CardiogenIc Shock - the TACTICS Study - a Randomized Controlled Trial
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-11-25
Completion Date
2027-07-01
Last Updated
2024-11-26
Healthy Volunteers
No
Conditions
Interventions
Acute TAVI
TAVI must be performed as soon as possible and within 12 hours of admission to the heart center.
Stabilization and subacute TAVI
Patients are stabilized according to target parameters. Treatment may include vasopressor, mechanical ventilation, renal replacement therapy, and blood transfusion. TAVI is then performed no earlier than 72 hours of admission to heart center.
Locations (2)
Rigshospitalet Copenhagen University Hospital
Copenhagen O, Denmark
Odense University Hospital
Odense C, Denmark