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Clinical Trials in Denmark / NCT06638268
Recruiting Not applicable

Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock

NCT06638268 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Not applicable
Started
2024-11-25
Last updated
2026-04-22

Condition(s) studied

Aortic StenosisCardiogenic Shock

Investigational drug(s) / intervention(s)

Acute TAVIStabilization and subacute TAVI

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

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.

Study 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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Days alive out of hospital — 90 days post-randomization
    Days alive out of hospital

Trial sites (1)

FacilityCityRegionStatus
Rigshospitalet Copenhagen University Hospital Copenhagen O Denmark Recruiting

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Other trials for the same condition

Low-Dose Dobutamine and Single-Dose Tocilizumab in Acute Myocardial Infarction With High Risk of Cardiogenic Shock Active, not recruiting
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis Recruiting
Comparison of Evolut FX Versus Sapien 3 Ultra Resilia. Active, not recruiting
Angiotensin Receptor Blockers in Aortic Stenosis Recruiting
Quality of Life After Transcatheter Aortic Valve Implantation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06638268 on ClinicalTrials.gov ↗ ← All trials in Denmark