Early transcatheter aortic valve replacement for critical aortic stenosis with cardiogenic shock
Official title: Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock - The TACTICS Study - A Randomized Controlled Trial
Run by Copenhagen University Hospital, Rigshospitalet · NCT06638268 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Copenhagen O) |
| Status | Recruiting |
| Started | November 25, 2024 |
| Main results expected | July 1, 2027 |
| Study ends | October 30, 2027 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT06638268 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Rigshospitalet Copenhagen University Hospital
Copenhagen O, Denmark Recruiting
Study contacts
- Study coordinator: Emil L Fosbøl, Professor, MD, PhD
- Email: emil.fosboel@regionh.dk
- Phone: 004535456340
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Exercise and nutrition support before and after TAVI for older adults with aortic stenosis
This trial tests whether a personalized exercise program plus protein and iron supplements before and after a transcatheter valve replacement can help older adults with aortic stenosis recover better than standard care.
-
Factors Influencing Outcomes in ECMO and Impella Patients
This study tests whether metabolic and thyroid hormone changes help predict survival for adults on ECMO or Impella at a single Hungarian cardiac ICU.
-
Evaluating a noninvasive tissue sensor to detect cardiogenic shock earlier in heart patients
This pilot, noninvasive study tests whether the NIRSense wearable can help detect deterioration in adults with cardiogenic shock risk due to heart attack or heart failure.
-
Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI
This study tests whether improvements in aortic valve opening after TAVI relate to reductions in lung congestion measured by ultrasound in adults with severe aortic stenosis.
-
Safety and Efficacy of an Extracorporeal Ventricular Assist System for Cardiogenic Shock
This study tests whether an extracorporeal ventricular assist device can safely provide short-term heart support and help patients with cardiogenic shock or trouble weaning from bypass.
-
Left Ventricular Support and Advanced Monitoring in AMI–Cardiogenic Shock: Immediate Impella Use and PAC/Monitoring vs Standard Care
In adults with heart attack-related cardiogenic shock, this trial tests whether using an Impella left ventricular assist device and/or protocolized pulmonary artery catheter monitoring improves survival compared with standard care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.