MedTrace Logo

Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock

NCT06638268 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-22

No results posted yet for this study

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

Conditions

  • Aortic Stenosis
  • Cardiogenic Shock

Interventions

PROCEDURE

Acute TAVI

TAVI must be performed as soon as possible and within 12 hours of admission to the heart center.

OTHER

Stabilization and subacute TAVI

Patients are stabilized according to target parameters. Treatment may include vasopressor, mechanical ventilation, renal replacement therapy, and blood transfusion. TAVI is then performed no earlier than 72 hours of admission to heart center.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-25
Primary Completion
2027-07-01
Completion
2027-10-30

Countries

  • Denmark

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06638268 on ClinicalTrials.gov