Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock
Recruiting now · Not applicable
Conditions studied: Aortic Stenosis, Cardiogenic Shock
In brief
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
Key facts
- Study ID
- NCT06638268
- Run by
- Rigshospitalet, Denmark
- People needed
- 30
- Starts
- 2024-11-25
- Expected to finish
- 2027-10-30
- Last updated by the study team
- 2026-04-22
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Rigshospitalet Copenhagen University Hospital — Copenhagen O, Denmark (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.