US-based medical devices developer Abiomed has started patient enrolment in the ST segment elevation myocardial infarction (STEMI) door to unloading (DTU) clinical study of its Impella CP system to treat acute myocardial infarction (MI).
Impella CP is a heart pump designed to pull blood from the left ventricle via an inlet area located near the tip while delivering it into the ascending aorta through the catheter.
The device can be inserted through the femoral artery, into the ascending aorta, across the valve and into the left ventricle using a traditional catheterisation procedure.
The prospective, multi-center study will enrol approximately 50 patients at ten sites.
It will evaluate the safety and feasibility of using the Impella CP to unload the left ventricle before primary percutaneous coronary intervention (PCI) in patients with STEMI and without cardiogenic shock.
Estimated to be completed within 18 months, the trial is being conducted on the assumption that the device will decrease the infarct size, myocardial workload and oxygen demand while initiating a cardio-protective effect.
The study's primary endpoints are safety and the adverse cardiovascular and cerebrovascular events (MACCE).
The infarct size as a percentage of left ventricular mass will be examined through cardiac magnetic resonance (CMR) imaging after 30 days of PCI.
Patients will receive Impella CP placement with immediate primary PCI or 30 minutes of unloading prior to primary PCI.