IMpella-Protected cArdiaC Surgery Trial (IMPACT)

NCT05529654 | Active Not Recruiting FDA Device

• 1 other identifier: VV-TMF-20447
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 20

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.

Conditions

Left Ventricular Dysfunction

Keywords

High-risk Cardiac Surgery; Low pre-operative left ventricular ejection fraction; Cardiopulmonary bypass (CPB); Temporary Mechanical Circulatory System (MCS)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• Number of attempts to wean from CPB

  Intra-op, usually within 1 day

• Duration of mechanical ventilation

  ICU discharge, usually within 30 days

• Duration and dosages of inotropes and vasopressors. Duration of mechanical circulatory support (Hours)

  ICU Discharge, usually within 30 days

• Acute Kidney Injury

  within 7 days or at ICU Discharge (usually within 30 days)

• Vasoactive-inotropic score (VIS)

  ICU Discharge, usually within 30 days

Study Arms (1)

Impella Arm

EXPERIMENTAL

Impella 5.5 with SmartAssist

Device: Impella 5.5 with SmartAssist

Interventions

Impella 5.5 with SmartAssist DEVICE

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

Impella Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Atrial septal defect (ASD) or patent foramen ovale (PFO) repair or closure
• Atrial fibrillation ablation procedures
• Left atrial ablation (all forms including complete left/right side Cox Maze)
• Coronary endarterectomy
• 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)
• Age 18 years or older

You may not qualify if:

• Salvage operation (cardiac arrest within 24 hours prior to index surgery)
• Unresponsive state within 24 hours of the time of surgery
• Any inotrope within 72 hours of surgery
• 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
• 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)

Sponsors & Collaborators

• Abiomed Inc.: lead

Study Sites (20)

Cardiology Associates Research Group

Jonesboro, Arkansas, 72401, United States

Location

Keck School of Medicine

Los Angeles, California, 90033, United States

Location

Tri-City Medical Center

San Diego, California, 92056, United States

Location

NCH Rooney Heart Institute

Naples, Florida, 34102, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's

Boston, Massachusetts, 02115, United States

Location

Minneapolis Heart Institute Foundation/Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

New York- Presbyterian Hospital/ Columbia University Medical Center

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Hospital of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Centennial Heart Cardiovascular

Nashville, Tennessee, 37203, United States

Location

University of Texas Austin Dell Medical School/Ascension Texas

Austin, Texas, 78705, United States

Location

Baylor Scott and White - Plano

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: September 7, 2022
• Study Start: September 21, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)