NCT03000270

Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study

Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Abiomed Inc. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible

Detailed description

A multi-center, prospective, randomized, two-arm feasibility trial to assess the potential role of unloading with the Impella CP prior to revascularization in reducing infarct size. The study design includes 1:1 randomization between: 1) Delay Arm: 30 minutes of unloading with Impella CP prior to primary percutaneous coronary intervention (PPCI); and 2) Immediate Arm: initiation of Impella CP unloading followed immediately by PPCI. Study Hypothesis: Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible

Conditions

• STEMI

Interventions

Type	Name	Description
DEVICE	Impella unloading prior to PPCI	Impella unloading prior to PPCI

Timeline

• Start date: 2017-04-11
• Primary completion: 2018-06-19
• Completion: 2018-08-16
• First posted: 2016-12-22
• Last updated: 2019-05-06

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study