cardiogenic shock heart failure
Conditions
Interventions
The PulseCath will be inserted in the heart via the subclavian artery. The tip
(inflow) will be positioned in the heart while the outflow opening will be
positioned outside the heart, in the aorta.
Sponsors
PulseCath BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Cardiac index (CI)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The procedure is considered safe when there were no CVA's, no thrombo-embolic events, and the degree of hemolysis was manageable. The efficacy of the device is considered established when the surgical introduction, positioning, fixation and removal of the device has been performed without any injury of valvular or vascular structures, and the device has not caused perfusion disorders of the peripheral arteries. The hemodynamic performance of the device is considered successful when CI > 2.5 L/min/m2 and MAP > 60 mmHg during all phases of the procedure, and the renal and liver functions did not deteriorate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical success is achieved when the patient has successfully been weaned from the device. | — |
Countries
Netherlands
Outcome results
None listed