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NOT YET RECRUITING
NCT06638268
NA

Transcatheter AortiC Valve Implantation in AorTic StenosIs CardiogenIc Shock

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Acute TAVI

TAVI must be performed as soon as possible and within 12 hours of admission to the heart center.

OTHER

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