Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock (TACTICS)

April 17, 2026 updated by: Emil Loldrup Fosbol, Rigshospitalet, Denmark

Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock - The TACTICS Study - A Randomized Controlled Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Aortic stenosis (AS) is a condition where the heart's aortic valve narrows. With an estimated prevalence of 12% in individuals aged 75 years and above, it is the most common heart valve disease. The progressive narrowing increases the afterload on the heart, impairing its ability to maintain cardiac output. The end-stage of critical AS is cardiogenic shock (CS) with an incidence of 3.5% to 12%. Without treatment, patients develop acute decompensation, organ failure, and ultimately die.

Guidelines suggest balloon aortic valvuloplasty (BAV), hemodynamic optimization in the intensive care unit and surgical aortic valve replacement or transcatheter aortic valve implantation (TAVI) when the patient is stable. Even with BAV, the 30-day mortality is 33%-47% and a 1-year mortality is 70%. Further, the BAV procedure is associated with only a minor and likely temporary reduction in afterload due to elastic valvular tissue. Furthermore, the BAV procedure has been abandoned as a routine intervention in these patients due to a series of patients having limited immediate clinical response, a risk of deterioration and no impact on overall mortality risk. Moreover, most patients with critical AS in CS are not candidates for surgical aortic valve replacement because of increased peri-operative risk of morbidity and mortality.

Despite the recommendation on TAVI under stable conditions, an acute TAVI may be efficient in afterload reduction and more efficient than the limited and transient effects of BAV. TAVI has become an attractive alternative to surgery and BAV because of the less invasive nature of this procedure, yet permanent result (compared with BAV). It is already approved for the treatment of AS irrespective of CS status. This raises the question:

"Should acute TAVI be the new preferred treatment strategy in AS patients in Cardiogenic shock?"

In this randomized controlled trial, we will include patients with severe aortic stenosis and cardiogenic shock. Patients will undergo either acute TAVI or standard treatment (stabilization in a cardiac intensive care unit and subsequently TAVI) in a 1:1 ratio. Outcomes are evaluated 90 days after randomization and comprise days alive out of hospital, mortality, cardiac function, renal function, and quality of life.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen O, Denmark, 2100
        • Recruiting
        • Rigshospitalet Copenhagen University Hospital
        • Contact:
        • Principal Investigator:
          • Emil L Fosbøl, Professor, MD, PhD
        • Principal Investigator:
          • Jesper Kjærgaard, Associate professor, DMSc, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute TAVI
Acute TAVI within 12 hours.
Procedure: Acute TAVI
TAVI must be performed as soon as possible and within 12 hours of admission to the heart center.
Active Comparator: Standard treatment
TAVI no earlier than 72 hours.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days alive out of hospital
Time Frame: 90 days post-randomization
Days alive out of hospital
90 days post-randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 days post-randomization
Rate of all-cause mortality
90 days post-randomization
LVEF
Time Frame: 90 days post-randomization
Left ventricular ejection fraction assessed with transthoracic echocardiography
90 days post-randomization
Clinical Frailty Scale
Time Frame: 90 days post-randomization
The Clinical Frailty Scale (CFS) is a tool used to assess a patient's level of frailty. The CFS ranges from 1 to 9, with higher scores indicating greater frailty.
90 days post-randomization
EQ-5D-5L
Time Frame: 90 days post-randomization
The EQ-5D-5L is a standardized instrument used to measure health-related quality of life. It is designed for use in clinical settings, research, and health evaluations, and provides a simple, yet comprehensive measure of a patient's overall health status. The "5D" refers to the five dimensions of health that it assesses, and the "5L" refers to the five levels of severity within each dimension.
90 days post-randomization
N-terminal-pro-brain- natriuretic peptide levels
Time Frame: 90 days post-randomization
Meassured in a blood sample
90 days post-randomization
eGFR
Time Frame: 90 days post-randomization.
Estimated glomerular filtration rate in mL/min/1.73m2 meassured in a blood sample.
90 days post-randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-24052460

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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