This record was last updated October 24, 2022 (before its estimated December 31, 2022 completion). Its status may not reflect the trial's current state.
Summary
To demonstrate that the Impella® Hemodynamic Platform (the "Study Device") is safe, and measurements obtained are as good as currently used methods. These measurements include how much pressure the heart is generating and how much blood your heart is pumping during the PCI.
Protocol Amendment History
12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2020-07-06; most recent amendment 2025-11-05.
Status change: Active, Not Recruiting → Completed2025-11-05
Status change: Recruiting → Active, Not Recruiting2022-10-20
Status change: Not Yet Recruiting → Recruiting2020-12-15