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:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT05064202
Eligibility Criteria:
Inclusion Criteria:
1\. Evidence of HFrEF according to ESC HF guidelines (LVEF ≤ 35%) 2. Signs of (persistent) congestion (elevated CVP, edema, rales, ascites, pleural effusion) 3. Evidence of CS with presence of at least 2 of the 3 following:
1. Hypotension
1. systolic blood pressure \<90 mmHg for at least 30 min OR
2. mean arterial pressure \<60 mmHg for at least 30 min
2. Hypoperfusion
1. lactate \> 2.0 mmol/L (two consecutive values \> 2 mmol/L with at least 30 min between samples, with non-decreasing trend on if on (steady doses of) inotropes and/or vasopressors)
2. amino-L-transferase \>200 U/L (two consecutive values \> 200 Ul/L with at least 30 min between samples, with non-decreasing trend if on (steady doses of) inotropes and/or vasopressors)
3. creatinine rise ≥ 0.3 mg/dl/24h ( 26,53 μmol/L)
4. oliguria (≤ 0,5 ml/kg/h, ≤ 720 ml/24 h)
3. Inotropes/vasoactives (use of)
Exclusion Criteria:
1. Contraindications for Impella 5.5
2. Severe concomitant RV failure
3. Grade IV mitral regurgitation eligible for surgical treatment
4. Dialysis for end-stage renal failure
5. Acute coronary syndrome (type 1, AMI)
6. Bradycardia and AV blocks necessitating pacemaker implantation
7. HD parameters and biochemistry alterations as specifically defined for SCAI CS E
8. Combined cardiorespiratory failure
9. Resuscitated (OHCA/PEA)
10. History of CVA or TIA within previous 90 days
11. History of acute myocardial infarction within previous 30 days
12. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions
13. Inflammatory
14. Active systemic infections
15. Acute myocarditis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05064202
Study Brief:
Protocol Section:
NCT05064202