NCT06638268 Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock
| NCT ID | NCT06638268 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Aortic Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-11-25 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-11-25 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06638268 clinical trial?
This trial is open to participants of all sexes, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06638268 currently recruiting?
Yes, NCT06638268 is actively recruiting participants. Contact the research team at emil.fosboel@regionh.dk for enrollment information.
Where is the NCT06638268 trial being conducted?
This trial is being conducted at Copenhagen O, Denmark.
Who is sponsoring the NCT06638268 clinical trial?
NCT06638268 is sponsored by Rigshospitalet, Denmark. The trial plans to enroll 30 participants.