Heart valve replacement timing in shock from aortic stenosis
Compares early valve replacement with stabilization first in people with heart shock.
Plain-language title generated from the registry record
Registry title: Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock
Key facts
- Where
- Copenhagen O, DenmarkSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with severe aortic valve narrowing who are in cardiogenic shock (the heart cannot pump enough blood). It compares a valve procedure (TAVI) within 12 hours with stabilization first and TAVI 72 hours or more later.
- Sex
- All sexes can join.
- Disease stage
- Aortic valve area less than 1cm2, with cardiogenic shock (poor blood flow to the body, low blood pressure or need for vasopressor medicine, and a weak heart pump with ejection fraction of 45% or less) or fainting or resuscitation needing a breathing machine.
- Biomarker or test result
- Arterial blood lactate of 2.5mmol/l or more (for the shock definition).
Main reasons for not taking part
- Bleeding in the brain less than 1 month ago
- Expected remaining life of less than 6 months from another cause
- Body mass index below 15 or above 40
- Clinical frailty score of 6 or more before the present worsening
- Severe lung disease, or judged unsuitable for TAVI before screening
Read by machine on 12 November 2026.
Where in Denmark
- Rigshospitalet Copenhagen University HospitalCopenhagen O, DenmarkContact: Emil L Fosbøl, Professor, MD, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Copenhagen University Hospital, Rigshospitalet
- Trial code
- NCT06638268
- Record updated
- 22 April 2026
- Original description
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.Read full original descriptionShow less
Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock - The TACTICS Study - A Randomized Controlled 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
Inclusion: 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: Unsuitable for TAVI prior to screening; Intracranial hemorrhage < 1 month ago; Severe lung disease (forced expiratory volume in 1 second OR diffusion capacity of the lungs for carbon monoxide < 25 of expected); Remaining life-expectancy < 6 month due to other cause; Body mass index <15 OR > 40; Clinical frailty score ≥6 before present worsening.