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IMPACT EU Post-Market Clinical Follow-Up Study

NCT05756751 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2025-09-30

No results posted yet for this study

Summary

The purpose of this trial is to collect further data on the safety and on the effectiveness of the use of Impella 5.5® in high-risk cardiac surgery patients.

Conditions

  • Left Ventricular Dysfunction

Interventions

DEVICE

Device: Impella 5.5 with SmartAssist

Patients who are deemed high-risk due to low preoperative ejection fraction undergoing cardiac surgery with cardiopulmonary bypass (CPB) which will be supported by the Impella 5.5 System.

Sponsors & Collaborators

  • Abiomed Inc.

    lead INDUSTRY

Principal Investigators

  • Hermann Reichenspurner, Prof. Dr. Dr. · UKE Hamburg

  • Payam Akhyari, Prof. Dr. · Westdeutsches Herz- und Gefäßzentrum Essen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-27
Primary Completion
2026-08-08
Completion
2026-08-08
FDA Device
Yes

Countries

  • Czechia
  • Germany

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 NCT05756751 on ClinicalTrials.gov