Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT06638268
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06638268
Study Brief:
Protocol Section:
NCT06638268