Transcatheter AortiC Valve Implantation in AorTic StenosIs CardiogenIc Shock

Launched by RIGSHOSPITALET, DENMARK · Oct 9, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called transcatheter aortic valve implantation (TAVI) for patients with severe aortic stenosis who are also experiencing cardiogenic shock, a serious condition where the heart isn't pumping enough blood. The study aims to find out if doing the TAVI procedure right away (within 12 hours of being admitted to the hospital) is better for survival compared to the standard approach, which involves stabilizing patients in the intensive care unit first and then performing TAVI 72 hours or more later.

To participate in this trial, you should have a narrowed aortic valve (less than 1 cm²) and show signs of cardiogenic shock, like low blood pressure or signs that your organs aren’t getting enough blood. If you qualify, you would either receive TAVI quickly after arriving at the hospital or after being stabilized. Throughout the study, you will have follow-up visits to check on your heart function and quality of life. It’s important to note that this trial is not yet recruiting participants, and there are certain medical conditions that may exclude you from participating, such as recent brain bleeding or severe lung disease.

Gender

ALL

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