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Race against time: can quick valve surgery save shock patients?

NCT ID NCT06638268

Disease control Sponsor: Rigshospitalet, Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether replacing a narrowed heart valve right away (within 12 hours) helps people with severe aortic stenosis who are in cardiogenic shock, compared to the usual approach of stabilizing them in the ICU first. Thirty participants will be randomly assigned to one of the two strategies. The main goal is to see if immediate treatment increases the number of days they are alive and out of the hospital.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcatheter aortic valve implantation (TAVI) procedure
What this could lead to
If it works, this could show that immediate valve replacement saves more lives than stabilizing patients first in the ICU.
What could go wrong
This is a very small early trial with only 30 participants, so results may not apply to everyone. The procedure itself carries risks like bleeding or stroke.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis cardiogenic shock Frailty Shock, Cardiogenic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis Cardiogenic shock

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rigshospitalet Copenhagen University Hospital

    RECRUITING

    Copenhagen O, 2100, Denmark

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