NL-OMON33512
Not yet recruiting
Not Applicable
Evaluation of the PulseCath, a Pulsatile Catheter Pump, in patients who need cardiac assist. - PulseCath 14 day study
PulseCath BV0 sites20 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- cardiogenic shock
- Sponsor
- PulseCath BV
- Enrollment
- 20
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Cardiac index (CI) \< 2\.2 L/min/m2, pre\-PulseCath, despite appropriate inotropic support and/or IABP
- •Mean arterial pressure (MAP) \< 60 mmHg, pre\-PulseCath, despite appropriate inotropic support and/or IABP
- •Expected duration of support by the PulseCath: 24 hours to 14 days
- •Patient older than 18 years
- •Patient or legal representative has signed the Informed Consent
Exclusion Criteria
- •Aortic disease: ascending aortic aneurism, severe calcified aorta
- •Aortic valvular disease: aortic valve stenosis, aortic valve insufficiency
- •Aortic valve prosthesis
- •Subclavian artery stenosis in case of insertion via subclavian artery
- •Thrombus in left ventricle
- •No residual function of the left ventricle
- •No functioning right ventricle
- •History of coagulation disorders
- •Previous history of CVA within the last 12 months
- •Liver dysfunction, evidenced by: ALT \> 100 U/L (men) \> 70 U/L (women) or AST \> 100 U/L (men) \> 70 U/L (women)
Outcomes
Primary Outcomes
Not specified
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