Actively Recruiting
Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock
Led by Rigshospitalet, Denmark · Updated on 2026-04-22
30
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aortic valve area less than 1 cm²
- Cardiogenic shock with peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5 mmol/l)
- Systolic blood pressure below 100 mmHg and/or need for vasopressor therapy (dopamine, norepinephrine, or epinephrine)
- Left ventricular ejection fraction 45% or less
- Syncope or resuscitation requiring mechanical ventilation
You will not qualify if you...
- Intracranial hemorrhage within the past month
- Life expectancy less than 6 months due to other causes
- Body mass index less than 15 or greater than 40
- Clinical frailty score 6 or higher before current worsening
- Severe lung disease with forced expiratory volume in 1 second or lung diffusion capacity for carbon monoxide less than 25% of expected
- Unsuitable for TAVI before screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Rigshospitalet Copenhagen University Hospital
Copenhagen O, Denmark, 2100
Actively Recruiting
Research Team
E
Emil L Fosbøl, Professor, MD, PhD
CONTACT
J
Jarl E Strange, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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