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Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock

RecruitingNAAges any - anyAllCopenhagen University Hospital, Rigshospitalet
NCT06638268 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • Acute TAVI
  • Stabilization and subacute TAVI
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Where

1 site
Rigshospitalet Copenhagen University Hospital
Copenhagen O, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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