Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock
Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock - The TACTICS Study - A Randomized Controlled Trial
Rigshospitalet, Denmark
30 participants
Nov 25, 2024
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria8
- Aortic valve area less than 1cm2
- AND
- Cardiogenic Shock defined as:
- Peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5mmol/l) AND
- Systolic blood pressure < 100 mmHg and/or need for vasopressor therapy (dopamine/ norepinephrine or epinephrine) AND
- Left ventricular ejection fraction ≤ 45%
- OR
- \- Syncope/resuscitation (mechanical ventilation)
Exclusion Criteria6
- Intracranial hemorrhage < 1 month ago
- Remaining life-expectancy < 6 month due to other cause
- Body mass index <15 OR > 40
- Clinical frailty score ≥6 before present worsening
- Severe lung disease (forced expiratory volume in 1 second OR diffusion capacity of the lungs for carbon monoxide < 25 of expected)
- Unsuitable for TAVI prior to screening
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Interventions
TAVI must be performed as soon as possible and within 12 hours of admission to the heart center.
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(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06638268