Early transcatheter aortic valve replacement for critical aortic stenosis with cardiogenic shock

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

This study will test whether doing a transcatheter aortic valve implantation within 12 hours helps people with critical aortic stenosis and cardiogenic shock survive and recover better than stabilizing them first and treating later.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sex: All
• Sponsor: Rigshospitalet, Denmark (other)
• Locations: 1 site (Copenhagen O)
• Trial ID: NCT06638268 on ClinicalTrials.gov

What this trial studies

This randomized interventional trial compares immediate TAVI (within 12 hours of admission) versus standard care with ICU stabilization and TAVI 72 hours or more after admission for patients with critical severe aortic stenosis presenting in cardiogenic shock. Eligible patients have an aortic valve area <1.0 cm2 and signs of cardiogenic shock (peripheral hypoperfusion with lactate ≥2.5 mmol/L, systolic blood pressure <100 mmHg or need for vasopressors, and left ventricular ejection fraction ≤45%) or recent syncope/resuscitation. Participants are randomized to one of the two timing strategies and will be followed with outpatient visits to measure survival, quality of life, and cardiac function. The trial is conducted at Rigshospitalet in Copenhagen and compares an acute afterload-reducing intervention against current stabilization-first practice.

Who should consider this trial

Good fit: Ideal candidates are adults with critical severe aortic stenosis (aortic valve area <1 cm2) who present in cardiogenic shock with hypoperfusion and hemodynamic instability or who require resuscitation.

Not a fit: Patients with recent intracranial hemorrhage, very limited life expectancy, extreme BMI (<15 or >40), high baseline frailty (score ≥6), severe lung disease, or who are unsuitable for TAVI are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, immediate TAVI could reduce early death and organ failure by quickly restoring valve function and improving cardiac output.

How similar studies have performed: While TAVI is well established for stable severe aortic stenosis, randomized evidence for performing TAVI acutely during cardiogenic shock is limited, so this approach remains relatively novel.

Eligibility criteria

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

Where this trial is running

Copenhagen O

• Rigshospitalet Copenhagen University Hospital — Copenhagen O, Denmark (RECRUITING)

Study contacts

• Study coordinator: Emil L Fosbøl, Professor, MD, PhD

Conditions: Aortic Stenosis, Cardiogenic Shock, Randomized Controlled Trial, Mortality, Frailty, Quality Of Life, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement