Aortic StenosisTACTICSNCT06638268
Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock
A study testing Acute TAVI and Stabilization and subacute TAVI in people with Aortic Stenosis and Cardiogenic Shock, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis, Cardiogenic Shock
- What is being tested?
- Acute TAVI and Stabilization and subacute TAVI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Nov 2024to 30 Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet Copenhagen University Hospital
Copenhagen O, 2100
Emil L Fosbøl, Professor, MD, PhD, 004535456340, emil.fosboel@regionh.dk
Emil L Fosbøl, Professor, MD, PhD
About this study
Official title: 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
Read the 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.
- Conditions
- Aortic Stenosis, Cardiogenic Shock
- Being tested
- Acute TAVI, Stabilization and subacute TAVI
- Keywords
- Randomized Controlled Trial, Cardiogenic Shock, Aortic Stenosis, Mortality, Frailty, Quality Of Life, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation
- Medical subject headings
- Aortic Valve Stenosis, Shock, Cardiogenic, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute TAVIProcedure or surgery
TAVI must be performed as soon as possible and within 12 hours of admission to the heart center.
Stabilization and subacute TAVIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute TAVI | Experimental | Acute TAVI within 12 hours. Receives: Procedure: Acute TAVI |
| Standard treatment | Active comparator | TAVI no earlier than 72 hours. Receives: Other: Stabilization and subacute TAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days alive out of hospital
Days alive out of hospital
Measured: 90 days post-randomization
Secondary outcomes (6)
Mortality
Rate of all-cause mortality
Measured: 90 days post-randomization
LVEF
Left ventricular ejection fraction assessed with transthoracic echocardiography
Measured: 90 days post-randomization
Clinical Frailty Scale
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.
Measured: 90 days post-randomization
EQ-5D-5L
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.
Measured: 90 days post-randomization
N-terminal-pro-brain- natriuretic peptide levels
Meassured in a blood sample
Measured: 90 days post-randomization
eGFR
Estimated glomerular filtration rate in mL/min/1.73m2 meassured in a blood sample.
Measured: 90 days post-randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start25 Nov 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized open label trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emil Loldrup Fosbol, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638268
- Sponsor's protocol ID
- H-24052460
- Acronym
- TACTICS
- Status last verified
- Apr 2026
- First submitted
- 9 Oct 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No