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Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock

ConditionsAortic StenosisCardiogenic Shock
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorRigshospitalet, Denmark

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Aortic valve area less than 1cm2

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%

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acute TAVI

    Procedure/Surgery

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

  • Stabilization and subacute TAVI

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Acute TAVIExperimental treatment 1 intervention
Group B: Standard treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Days alive out of hospital

Days alive out of hospital

Time frame
90 days post-randomization

Secondary outcomes

1

Mortality

Rate of all-cause mortality

Time frame
90 days post-randomization
2

LVEF

Left ventricular ejection fraction assessed with transthoracic echocardiography

Time frame
90 days post-randomization
3

Clinical Frailty Scale

The Clinical Frailty Scale (CFS) is a tool used to assess a patient\&#39;s level of frailty. The CFS ranges from 1 to 9, with higher scores indicating greater frailty.

Time frame
90 days post-randomization
4

EQ-5D-5L

The EQ-5D-5L is a standardized instrument used to measure health-related quality of life. It is designed for use in clinical settings, research, and health evaluations, and provides a simple, yet comprehensive measure of a patient\&#39;s overall health status. The \&#34;5D\&#34; refers to the five dimensions of health that it assesses, and the \&#34;5L\&#34; refers to the five levels of severity within each dimension.

Time frame
90 days post-randomization

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Rigshospitalet Copenhagen University HospitalRecruiting2100, Copenhagen ODenmarkDenmark

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Source ClinicalTrials.gov
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