Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock

NCT06638268 | Recruiting

• 1 other identifier: H-24052460
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Aortic Stenosis; Cardiogenic Shock

Keywords

Randomized Controlled Trial; Cardiogenic Shock; Aortic Stenosis; Mortality; Frailty; Quality Of Life; Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement; Transcatheter Aortic Valve Implantation

Outcome Measures

Primary Outcomes (1)

• Days alive out of hospital

  Days alive out of hospital

  90 days post-randomization

Secondary Outcomes (6)

• Mortality

  90 days post-randomization

• LVEF

  90 days post-randomization

• Clinical Frailty Scale

  90 days post-randomization

• EQ-5D-5L

  90 days post-randomization

• N-terminal-pro-brain- natriuretic peptide levels

  90 days post-randomization

Study Arms (2)

Acute TAVI

EXPERIMENTAL

Acute TAVI within 12 hours.

Procedure: Acute TAVI

Standard treatment

ACTIVE COMPARATOR

TAVI no earlier than 72 hours.

Other: Stabilization and subacute TAVI

Interventions

Acute TAVI PROCEDURE

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

Acute TAVI

Stabilization and subacute TAVI OTHER

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.

Standard treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• \- Syncope/resuscitation (mechanical ventilation)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet Copenhagen University Hospital

Copenhagen O, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Shock, Cardiogenic; Frailty

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Central Study Contacts

Emil L Fosbøl, Professor, MD, PhD

CONTACT

004535456340; emil.fosboel@regionh.dk

Jarl E Strange, MD, PhD

CONTACT

004560616598; jarl.emanuel.strange.02@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized open label trial

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)