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 @ 2:09 PM
Ignite Modification Date:
2025-12-24 @ 2:09 PM
NCT ID:
NCT05577195
Eligibility Criteria:
Inclusion Criteria:
Severe cardiogenic shock due to severe left ventricular dysfunction:
* Systolic blood pressure \<90 mmHg or need for catecholamines to maintain such blood pressure
* Signs of impaired organ perfusion with at least one of the following: altered mental status OR cold, clammy skin OR oliguria with urine output \<30 ml/h
* Arterial lactate \>5 mmol/l
Exclusion Criteria:
* Post-cardiotomy cardiogenic shock.
* Cardiogenic shock due to acute rejection in heart transplant recipients.
* Obstructive cardiogenic shock (e.g. cardiogenic shock due to fulminant pulmonary embolism)
* Cardiogenic shock due to other causes (e.g. bleeding, hypothermia)
* Pre-existing Impella treatment.
* Onset of shock \>12 hours.
* Mechanical complication of acute myocardial infarction.
* Prolonged resuscitation (\>60 minutes).
* Severe peripheral artery disease with infeasibility for Impella or veno-arterial extracorporeal membrane oxygenation implantation.
* Age \<18 or \>80 years.
* Other severe concomitant disease with life expectancy \<6 months.
* Participation in another trial with an intervention or pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05577195
Study Brief:
Protocol Section:
NCT05577195