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Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial

NCT03947619 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 527

Last updated 2026-03-06

No results posted yet for this study

Summary

The purpose of this research study is to evaluate whether using the the IMPELLA® CP System temporary circulatory assist device for 30 minutes prior to a catheterization procedure has the potential to reduce the damage to the heart caused by a heart attack, compared to the current standard of care.

Conditions

  • ST Elevation (STEMI) Myocardial Infarction of Anterior Wall

Interventions

DEVICE

Impella CP® placement prior to reperfusion with Primary PCI

Subjects randomized to the experimental arm, will undergo Impella CP® placement through a femoral arterial sheath and the Impella device will be activated to unload the left ventricle.

Sponsors & Collaborators

  • Abiomed Inc.

    lead INDUSTRY

Principal Investigators

  • William O'Neill, MD · Henry Ford Hospital

  • Norman Mangner, Prof. Dr. med. habil. · Heart Center Dresden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-12
Primary Completion
2024-09-04
Completion
2030-10-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Germany
  • Italy
  • Switzerland
  • United Kingdom

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 NCT03947619 on ClinicalTrials.gov