Health Trials

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

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

Treatments tested in this trial

  • Acute TAVI
  • Stabilization and subacute TAVI

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

1

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

Rigshospitalet Copenhagen University HospitalRecruiting2100, Copenhagen ODenmarkDenmark

Sponsors and collaborators

Rigshospitalet, Denmark

Lead sponsor

Source ClinicalTrials.gov