NCT03947619

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 527 (actual)
• Sponsor: Abiomed Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To demonstrate the safety and effectiveness of primary Left Ventricular unloading and a thirty-minutes delay to reperfusion vs. current standard of care in reducing infarct size and heart failure-related clinical events in patients presenting with anterior ST-Elevation Myocardial Infarction.

Conditions

• ST Elevation (STEMI) Myocardial Infarction of Anterior Wall

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-12
• Primary completion: 2024-09-04
• Completion: 2030-10-01
• First posted: 2019-05-13
• Last updated: 2026-03-06

Locations

63 sites across 6 countries: United States, Canada, Germany, Italy, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study