Evaluation of the PulseCath, a Pulsatile Catheter Pump, in patients who need cardiac assist.

Conditions: cardiogenic shock
heart failure
10019280

Registration Number: NL-OMON33512

Lead Sponsor: PulseCath BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

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)
• Patients with chronic renal failure requiring dialysis
• Participation in another clinical study that may interfere with this study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The procedure is considered safe when there were no CVA's, no thrombo-embolic<br /><br>events, and the degree of hemolysis was manageable. The efficacy of the device<br /><br>is considered established when the surgical introduction, positioning, fixation<br /><br>and removal of the device has been performed without any injury of valvular or<br /><br>vascular structures, and the device has not caused perfusion disorders of the<br /><br>peripheral arteries. The hemodynamic performance of the device is considered<br /><br>successful when CI > 2.5 L/min/m2 and MAP > 60 mmHg during all phases of the<br /><br>procedure, and the renal and liver functions did not deteriorate. </p><br>

Secondary Outcome Measures