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Enrollment begins for feasibility study of heart pump in patients with STEMI needing PCI
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The first patients have been enrolled in an FDA-approved feasibility study to evaluate a heart pump for reduction of infarct size in patients with STEMI requiring PCI, according to a press release from Abiomed.
The study will assess the safety of the heart pump system (Impella CP, Abiomed) for unloading of the left ventricle prior to PCI in patients with STEMI without cardiogenic shock.
Navin K. Kapur, MD, associate professor at Tufts Medical Center, Boston, and colleagues hypothesize that the Impella CP system could reduce myocardial work load, oxygen demand and initiate a protective effect, which may alleviate myocardial damage, according to the release.
The researchers aim to enroll up to 50 participants, who will be randomly assigned to receive the heart pump with immediate primary PCI or heart pump placement with 30 minutes of unloading prior to PCI, according to the release. Cardiac MRI will be used to assess infarct size.
The primary endpoints will focus on safety, including incidence of adverse CV and cerebrovascular events at 30 days.
The study is expected to be completed in 18 months, and its results could inform the basis of a larger pivotal study, the company stated in the release.