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IMpella-Protected cArdiaC Surgery Trial (IMPACT)

NCT05529654 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-12

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Abiomed Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Goldstein, MD · Montefiore Medical Center

  • Edward Soltesz, MD · The Cleveland Clinic

  • Hermann Reichenspurner, MD, PhD · University Heart & Vascular Center Hamburg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-21
Primary Completion
2025-11-04
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05529654 on ClinicalTrials.gov