IMPACT EU Post-Market Clinical Follow-Up Study

Study Overview
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Brief Summary
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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.

Detailed Description
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A European, prospective, multicenter, post-market clinical single-arm follow-up trial with an adaptive design. The study will first include up to 123 patients, but the adaptive mechanism can allow the sample size to increase up to 535 patients. 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 improving functional status and quality of life (QoL) in high-risk cardiac surgery patients with severe LV dysfunction in a post-market setting.

Official Title
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IMpella®-Protected cArdiaC Surgery Trial in Europe: A European, Prospective, Multicenter, Post-Market Clinical Follow-Up Trial

Conditions
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Left Ventricular Dysfunction

Intervention / Treatment
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* Device: Device: Impella 5.5 with SmartAssist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemodynamically stable patients undergoing one (1) of the following cardiac surgery procedures on CPB including aortic cross-clamping and cardioplegic arrest Isolated CABG Isolated mitral valve repair or replacement (MVR) Mitral and tricuspid valve repair or replacement (MVR/TVR) CABG and mitral valve repair or replacement (CABG/MVR) CABG and mitral valve repair or replacement and tricuspid valve repair or replacement (CABG/MVR/TVR) CABG and tricuspid valve repair or replacement (CABG/TVR) LVEF within 30 days before surgery of either: ≤30% measured by echocardiogram or LVEF ≤35% as above for patients with significant mitral regurgitation (MR 3+ or 4+; see definition) and planned corrective mitral valve surgery (including MV replacement or repair) Age 18 years or older Subject has signed informed consent form and is willing and able to attend all follow-up visits and to perform all tests. Patient is eligible to receive the Impella 5.5 as per the current IFU. Exclusion Criteria: Salvage operation (cardiac arrest within 24 hours prior to index surgery) Unresponsive state within 24 hours of the time of surgery Cardiogenic shock at the time of index surgery Any mechanical MCS device (such as IABP, ECMO, Impella®, CentriMag™ or TandemHeart®) in place prior to informed consent RV dysfunction requiring mechanical or inotropic support preoperatively and/or likely to be needed postoperatively Index procedures requiring total circulatory arrest (TCA), such as aortic arch replacement, planned durable LVAD, durable RVAD, planned right-sided temporary mechanical support of any kind, total artificial heart (TAH), cardiac transplantation, pericardiectomy, pulmonary thromboendarterectomy and septal myectomy Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade or other conditions in which cardiac output is dependent on venous return Ventricular septal defect (VSD) Stroke within 30 days of the index cardiac surgical procedure Prior mantle field chest irradiation Prior solid organ or hematologic transplantation (heart, kidney, liver, lung, pancreas, bone marrow) or durable LVAD History of chronic dialysis Pre-existing liver dysfunction defined as Child-Pugh Class B or C Pre-existing pulmonary disease requiring home oxygen, or severe pulmonary disease determined by enrolling investigator Systemic active infection or evidence of systemic bacterial, fungal or viral infection within 72 hours before surgery (blood culture positive with leukocytosis) Confirmed COVID-19 infection within two (2) weeks prior to operation Pregnant or planning pregnancy within next 12 months. NOTE: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention. Participation in the active treatment or follow-up phase of another interventional clinical trial of an investigational drug or device which has not reached its primary endpoint Known contraindication to heparin; History of bleeding diathesis or known coagulopathy or will refuse blood transfusions Inability to perform aortic cross-clamp, such as due to porcelain aorta Any contraindication or condition that would prevent the ability to place Impella 5.5® (per current IFU), including LV thrombus and/or presence of a mechanical aortic valve Any organ condition, concomitant disease (e.g., psychiatric illness, current severe alcoholism or current drug abuse, cancer, hepatic or kidney disease), with life expectancy of ≤2 years or other abnormality that itself or the treatment of which, could interfere with the conduct of the trial or that, in the opinion of the investigator would pose an unacceptable risk to the subject in the trial. Subject has other medical, social or psychological problems that, in the opinion of the investigator, compromises the subject's ability to give written informed consent and/or to comply with trial procedures, including patients under guardianship Any subject considered to be part of a vulnerable population (as per ISO 14155)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Impella 5.5® with SmartAssist® (Impella 5.5®)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment with Impella 5.5 System<br> | Device: Device: Impella 5.5 with SmartAssist<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of post-cardiotomy cardiac failure |  | Through Hospital Discharge, on average 1 week | 
| All-cause mortality and Safety Endpoint: Stroke (as defined by STS) |  | 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. | 90 Days after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New requirement for renal replacement therapy (RRT) |  | through study completion, an average of 1 year | 
| Number of attempts to wean from CPB |  | Until CPB was removed, on average 72 hours | 
| Duration and dosages of vasopresor ssupport in hours |  | Through ICU Discharge, on average 3 days | 
| Duration and dosages of inotropic support in hours |  | Through ICU Discharge, on average 3 days | 
| Acute Kidney Injury (a modified KDIGO stages 2-3) |  | Within 7 days or at ICU discharge whichever comes first | 
| Adequate hemodynamic support |  | Through ICU Discharge, on average 3 days | 
| Major Hemolysis (defined by MCS-ARC) |  | Through Hospital Discharge, on average 1 week | 
| Major Vascular Complications (defined by MCS-ARC) |  | Through Hospital Discharge, on average 1 week | 
| Major Bleeding defined by STS | Bleeding requiring surgical intervention or fatal bleeding | Through Hospital Discharge, on average 1 week | 
| All-cause Mortality |  | Up to 1-year post-op |