The purpose of this trial is to collect further data on the safety and on the effectiveness of the use of Impella 5.5® in high-risk cardiac surgery patients.
A European, prospective, multicenter, post-market clinical single-arm follow-up trial. Up to 123 patients will be enrolled in the study. Patients will be followed for up to 1-year. The objectives of the study are to collect data on the safety and on the effectiveness of the Impella 5.5 System in mitigating post-cardiotomy cardiac failure, as well as improving functional status and quality of life (QoL) in high-risk cardiac surgery patients with severe LV dysfunction in a post-market setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
123
Patients who are deemed high-risk due to low preoperative ejection fraction undergoing cardiac surgery with cardiopulmonary bypass (CPB) which will be supported by the Impella 5.5 System.
IKEM Prague
Prague, Czechia
Universitätsklinikum Heidelberg - Klinik für Herzchirurgie
Heidelberg, Baden-Wurttemberg, Germany
the rate of post-cardiotomy cardiac failure
Time frame: Through Hospital Discharge, on average 1 week
All-cause mortality
Time frame: 90 Days after procedure
Stroke (as defined by STS)
Postoperative stroke (cerebrovascular accident) consisting of any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain that did not resolve within 24 hours.
Time frame: 90 Days after procedure
New requirement for renal replacement therapy (RRT)
Time frame: through study completion, an average of 1 year
Number of attempts to wean from CPB
Time frame: Until CPB was removed, on average 72 hours
Duration of mechanical ventilation
Time frame: Through ICU Discharge, on average 3 days
Acute Kidney Injury (a modified KDIGO stages 2-3)
Time frame: Within 7 days or at ICU discharge whichever comes first
Adequate hemodynamic support
Time frame: Until Pulmonary Artery Catheter was removed, on average 3 days
Vasoactive-inotropic score (VIS)
Time frame: Through ICU Discharge, on average 3 days
Cardiovascular mortality
Time frame: Through Hospital Discharge, on average 1 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
RWTH Uniklinik Aachen - Klinik für Herzchirurgie
Aachen, North Rhine-Westphalia, Germany
Universitätsklinikum Düsseldorf, Klinik für Herzchirurgie
Düsseldorf, North Rhine-Westphalia, Germany
Universitätsmedizin Essen, Westdeutsches Herzzentrum, Klinik für Thorax- und Kardiovaskuläre Medizin
Essen, North Rhine-Westphalia, Germany
Universitätsmedizin Mainz, Klinik und Poliklinik für Herz- und Gefäßchirurgie
Mainz, RLP, Germany
Universitätsmedizin Halle/Saale - Klinik für Herzchirurgie
Halle, SA, Germany
UKSH Campus Kiel - Klinik für Herz- und Gefäßchirurgie
Kiel, Schleswig-Holstein, Germany
Deutsches Herzzentrum der Charité
Berlin, Germany
Universitätsklinikum Giessen
Giessen, Germany
...and 3 more locations
Major Hemolysis (defined by MCS-ARC)
Time frame: Through Hospital Discharge, on average 1 week
Major Vascular Complications (defined by MCS-ARC)
Time frame: Through Hospital Discharge, on average 1 week
Major Bleeding defined by STS
Bleeding requiring surgical intervention or fatal bleeding
Time frame: Through Hospital Discharge, on average 1 week
All-cause Mortality
Time frame: Up to 1-year post-op