IMpella-Protected cArdiaC Surgery Trial (IMPACT) (IMPACT)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Left Ventricular Dysfunction
• Intervention / Treatment: Device: Impella 5.5 with SmartAssist

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine
  • Florida
    • Orlando, Florida, United States, 32804
      • Advent Health - Orlando
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Mass General Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes- Jewish Hospital
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10032
      • New York- Presbyterian Hospital/ Columbia University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Centennial Heart Cardiovascular
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Plano, Texas, United States, 75093
      • Baylor Scott and White - Plano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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:

     1. Atrial septal defect (ASD) or patent foramen ovale (PFO) repair or closure
     2. Closure or excision of left atrial appendage (LAA)
     3. Left atrial ablation (all forms including complete left/right side Cox Maze)
     4. Coronary endarterectomy

2. 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)
3. Age 18 years or older
4. Subject (or subject's LAR, if allowed by IRB) has signed Informed Consent Form

Exclusion Criteria:

1. Salvage operation (cardiac arrest within 24 hours prior to index surgery)
2. Unresponsive state within 24 hours of the time of surgery
3. Cardiogenic shock at the time of index surgery
4. Any MCS device (such as IABP, ECMO, Impella®, CentriMag™ or TandemHeart®) in place prior to informed consent
5. RV dysfunction requiring mechanical or inotropic support pre-operatively and/or likely to be needed post-operatively
6. 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
7. Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade or other conditions in which cardiac output is dependent on venous return
8. Ventricular septal defect (VSD)
9. Stroke within 30 days of the index cardiac surgical procedure
10. Prior mantle field chest irradiation
11. Prior solid organ or hematologic transplantation (heart, kidney, liver, lung, pancreas, bone marrow) or durable LVAD
12. History of chronic dialysis
13. Pre-existing liver dysfunction defined as: Child-Pugh Class B or C
14. Pre-existing pulmonary disease requiring home oxygen or "severe pulmonary disease" determined by enrolling Investigator
15. Systemic active infection or evidence of systemic bacterial, fungal or viral infection within 72 hours before surgery (blood culture positive with leukocytosis)
16. Confirmed COVID-19 infection within two weeks prior to operation
17. Suspected or known pregnancy
18. 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
19. Known contraindication to heparin; History of bleeding diathesis or known coagulopathy or will refuse blood transfusions
20. Inability to perform aortic cross-clamp, such as due to porcelain aorta
21. Any contraindication or inability to place Impella 5.5 (per the IFU), including LV thrombus and/or presence of a mechanical aortic valve
22. 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.
23. 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
24. 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]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Abiomed Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: High-risk Cardiac Surgery; Low pre-operative left ventricular ejection fraction; Cardiopulmonary bypass (CPB); Temporary Mechanical Circulatory System (MCS)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Left
• Other Study ID Numbers: VV-TMF-20447

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes