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: Active, not recruiting
• 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 if using Impella 5.5 peri-operatively improves early hemodynamics, end-organ function and subsequent clinical outcomes in patients with severely reduced LV function undergoing cardiac surgery.

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

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Cardiology Associates Research Group
  • California
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine
    • San Diego, California, United States, 92056
      • Tri-City Medical Center
  • Florida
    • Naples, Florida, United States, 34102
      • NCH Rooney Heart Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's
    • Boston, Massachusetts, United States, 02114
      • Mass General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation/Abbott Northwestern Hospital
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • 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
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • New Hanover Regional 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
    • Austin, Texas, United States, 78705
      • University of Texas Austin Dell Medical School/Ascension Texas
    • 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. Hemodynamically stable patients undergoing one of the following cardiac surgery procedures on CPB including aortic cross-clamping and cardioplegic arrest:

   • Isolated CABG
   • Isolated mitral valve repair or mitral valve replacement (MVR)
   • Isolated biological aortic valve replacement (AVR)
   • At least two of the following: CABG, MVR, AVR, or tricuspid valve repair or replacement (TVR)

   • Additional concomitant procedures permitted:

     1. Atrial septal defect (ASD) or patent foramen ovale (PFO) repair or closure
     2. Atrial fibrillation ablation procedures
     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:

   • ≤25% measured by echocardiogram or cardiac MRI, OR

   • LVEF ≤35%, measured as above, for patients with significant mitral regurgitation (MR 3+ or 4+) and planned corrective mitral valve surgery (including MV replacement or repair)

     • Any subject with EF <20% must have viability assessment performed to assess CABG candidacy (MRI preferred)
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. Any inotrope within 72 hours of surgery
4. Any MCS device (such as IABP, ECMO, Impella®, CentriMag™ or TandemHeart®) in place at time of informed consent and less than 24 hours prior to index study procedure
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 patient in the trial.
23. Patient 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. Patient belongs to a vulnerable population [Vulnerable patient populations are defined as individuals with mental disability, persons in nursing homes, children, 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	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
Rate of Post-Cardiotomy Cardiac Failure	The rate of post-cardiotomy cardiac failure evaluated at hospital discharge.	Hospital discharge, usually within 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of attempts to wean from CPB		Intra-op, usually within 1 day
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
Duration of mechanical ventilation		ICU discharge, usually within 30 days
Cardiovascular mortality		Hospital discharge, usually within 30 days
Duration and dosages of inotropes and vasopressors. Duration of mechanical circulatory support (Hours)	measured in number of hours of dosage	ICU Discharge, usually within 30 days
Acute Kidney Injury	a modified KDIGO Stages 2-3	within 7 days or at ICU Discharge (usually within 30 days)
Vasoactive-inotropic score (VIS)		ICU Discharge, usually within 30 days

Collaborators and Investigators

• Sponsor: Abiomed Inc.
• Investigators: Principal Investigator: Daniel Goldstein, MD, Montefiore Medical Center; Principal Investigator: Edward Soltesz, MD, The Cleveland Clinic; Principal Investigator: Hermann Reichenspurner, MD, PhD, University Heart & Vascular Center Hamburg

Publications and helpful links

General Publications

• Goldstein DJ, Reichenspurner H, Vorovich E, Teuteberg J, Ramzy D, Lobdell KW, Parks RJ, May A, Aggarwal S, Soltesz EG. Design and rationale of the Impella(R)-protected cardiac surgery trial (IMPACT): A multicenter, single-arm pilot study in high-risk cardiac surgery patients. Am Heart J. 2026 Mar 25;297:107434. doi: 10.1016/j.ahj.2026.107434. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Actual): November 4, 2025
• Study Completion (Estimated): July 1, 2026

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): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

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: Cardiovascular Diseases; Heart 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