IMpella-Protected cArdiaC Surgery Trial (IMPACT)

Study Overview
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Brief Summary
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The purpose of this Trial is to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients, with the overall aim to evaluate if using Impella 5.5 with SmartAssist (Impella 5.5) peri-operatively improves early hemodynamics, end-organ function and clinical outcomes in patients with severely reduced LV function undergoing cardiac surgery.

Detailed Description
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This is a prospective single-armed Trial to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients. A concurrent Registry will also be performed to collect information on patients meeting Exclusion Criteria and those not approached for enrollment. The overall aim is to evaluate the safety and effectiveness of using Impella 5.5 preemptively in high-risk cardiac surgery patients with severe LV dysfunction. This Trial will determine whether using the Impella 5.5 in this setting will result in an acceptable device-related safety profile.

Official Title
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IMpella-Protected cArdiaC Surgery Trial (IMPACT)

Conditions
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Left Ventricular Dysfunction

Intervention / Treatment
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* Device: Impella 5.5 with SmartAssist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing one of the following elective or urgent (within 24 hours from admission) 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) Additional concomitant procedures permitted: Atrial septal defect (ASD) or patent foramen ovale (PFO) repair or closure Closure or excision of left atrial appendage (LAA) Left atrial ablation (all forms including complete left/right side Cox Maze) Coronary endarterectomy 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+) and planned corrective mitral valve surgery (including MV replacement or repair) Age 18 years or older Subject (or subject's LAR, if allowed by IRB) has signed Informed Consent Form 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 MCS device (such as IABP, ECMO, Impella®, CentriMag™ or TandemHeart®) in place prior to informed consent RV dysfunction requiring mechanical or inotropic support pre-operatively and/or likely to be needed post-operatively 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 weeks prior to operation Suspected or known pregnancy 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 inability to place Impella 5.5 (per the 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 and/or Sponsor's Medical Monitor, 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 Subject belongs to a vulnerable population [Vulnerable Patient Populations are defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention]

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Impella Arm<br>Impella 5.5 with SmartAssist | Device: Impella 5.5 with SmartAssist<br>* For subjects enrolled in the Trial, the Impella 5.5 will be placed intra-operatively during the index cardiac surgical procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of All-Cause Mortality |  | 90 days | 
| Stroke (as defined by STS) |  | 90 days | 
| New requirement for Renal Replacement Therapy (RRT) |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of attempts to wean from CPB |  | Intra-op, usually within 1 day | 
| Duration of mechanical support (hours) |  | ICU Discharge, usually within 30 days | 
| Hemodynamics: Adequate hemodynamic support | As defined by stable CI, CO, CPI, MAP, CVP, pulmonary artery diastolic pressureWill also be assessed by Vasoactive-Inotropic Score (VIS) | Every 4 hours for first 72 hours post-op and then every 12 hours until removal of pulmonary artery catheter until ICU Discharge | 
| Major Hemolysis | defined by MCS-ARC | Hospital Discharge, usually within 30 days | 
| Major Vascular Complications | defined by MCS-ARC | Hospital Discharge, usually within 30 days | 
| Major Bleeding | defined by STS | Hospital Discharge, usually within 30 days | 
| Length of ICU Stay |  | ICU Discharge, usually within 30 days | 
| Length of Hospital Stay |  | Hospital Discharge, usually within 30 days | 
| Quality of Life (QoL) assessed by KCCQ |  | 90 Days Post-Op | 
| Physical Activity | Measured by (Katz Activities of Daily Living (ADL) and Lawton Instrumental ADL (IADL) | 90 Days Post-Op | 
| Technical Success | The successful use of the Impella 5.5 device will be assessed by the proportion of patients who undergo successful Impella implant, as well as the proportion of patients demonstrating successful wean off CPB. | Intra-op, usually within 1 day | 
| Acute Kidney Injury | a modified KDIGO Stages 2-3 | within 7 days or at ICU Discharge | 
| Dosages for inotropic/vasopressor (Hours) | measured in number of hours of dosage | ICU Discharge, usually within 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-risk Cardiac Surgery, Low pre-operative left ventricular ejection fraction, Cardiopulmonary bypass (CPB), Temporary Mechanical Circulatory System (MCS)