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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Subjects will receive the Impella® with the Impella® Hemodynamics Platform prior to High risk percutaneous coronary intervention (HRPCI). Device escalation or early termination of the study will be allowed for subjects as deemed necessary by the treating physician. Subjects will be consented for follow-up through discharge from the index HRPCI admission.
Ochsner Clinical Foundation
New Orleans, Louisiana, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Ascension St. John Hospital
Detroit, Michigan, United States
The ability to calculate and display cardiac output (CO).
Defined as the number of times a CO calibration sequence is successfully completed and the CO is displayed divided by the number of times the pinging sequence is attempted. The endpoint is a rate and therefore has no units of measure. It is the "number of times CO was successfully completed, and CO is displayed" divided by the "number of times the pinging sequence was attempted"
Time frame: Through study completion, approximately 2 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Spectrum Health
Grand Rapids, Michigan, United States
Columbia University Medical Center
New York, New York, United States