IMpella-Protected cArdiaC Surgery Trial (IMPACT)

NCT ID: NCT05529654

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-21
• Study Completion Date: 2025-10-31

Brief Summary

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

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.

Conditions

Left Ventricular Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Impella Arm

Impella 5.5 with SmartAssist

Group Type: EXPERIMENTAL

Impella 5.5 with SmartAssist

Intervention Type: DEVICE

For subjects enrolled in the Trial, the Impella 5.5 will be placed intra-operatively during the index cardiac surgical procedure

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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]

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abiomed Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Edward Soltesz, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Hermann Reichenspurner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Heart & Vascular Center Hamburg

Locations

Cardiology Associates Research Group

Jonesboro, Arkansas, United States

Keck School of Medicine

Los Angeles, California, United States

Tri-City Medical Center

San Diego, California, United States

NCH Rooney Heart Institute

Naples, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Mass General Hospital

Boston, Massachusetts, United States

Brigham & Women's

Boston, Massachusetts, United States

Minneapolis Heart Institute Foundation/Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

NYU Langone Health

New York, New York, United States

New York- Presbyterian Hospital/ Columbia University Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

New Hanover Regional Medical Center

Wilmington, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

Hospital of The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Centennial Heart Cardiovascular

Nashville, Tennessee, United States

University of Texas Austin Dell Medical School/Ascension Texas

Austin, Texas, United States

Baylor Scott and White - Plano

Plano, Texas, United States

Countries

United States

Other Identifiers

VV-TMF-20447

Identifier Type: -

Identifier Source: org_study_id