NCT06638268Recruiting
Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock
Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock - The TACTICS Study - A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 9 Oct 2024
- Start date
- 25 Nov 2024
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- NCT number
- NCT06638268
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 25 Nov 2024 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unsuitable for TAVI prior to screening
Other illness
- 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)
Other
- Remaining life-expectancy \< 6 month due to other cause
- Body mass index \<15 OR \> 40
- Clinical frailty score ≥6 before present worsening
Who the study is looking for
- 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)
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet Copenhagen University Hospital Coordinator of this site? Confirm its status | Copenhagen O | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.