Impella BTR

Use of the Impella BTR™ in Patients With Heart Failure: An Early Feasibility Study (BTR EFS)

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Overview
Principal Investigator: Michael Kiernan

This is a prospective, multi-center, single-arm, early feasibility study that aims to evaluate the safety of the Impella BTR™ in adult patients requiring left-ventricular hemodynamic support, and to evaluate the effectiveness of the Impella BTR™ in supporting patients to recovery or their next therapy.

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Gaurav Das

Study details
Inclusion Criteria
  • Subject has pre-existing heart failure, with NYHA Class IV prior to the index admission
  • Subject is presenting with acute heart failure and meets one of the following criteria:
    a. Sustained episode of systolic blood pressure ≤90 mmHg for at least 30 minutes or need for vasoactive agents to maintain such blood pressure
    b. Or a cardiac index (CI) <2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia
    c. Or required support with an intra-aortic balloon pump
  • Age ≥18 years
Exclusion Criteria
  • Structural aortic valve regurgitation or stenosis of any grade greater than mild, with evidence of aortic sclerosis on pre-procedure echocardiography
  • New diagnosis of heart failure ≤90 days prior to enrollment
  • Previous aortic valve replacement or reconstruction
Study Requirements

Following informed consent, subjects that meet all of the inclusion and none of the exclusion criteria, and in whom the Impella BTR is implanted or attempted to be implanted, will be considered enrolled into the Study. The device is inserted during a surgical procedure through a vascular graft that has been sutured onto the left or right axillary artery. After proper placement and passage through the aortic valve with the help of a guidewire, the device pumps blood from the left ventricle into the aorta. Once hemodynamic support is no longer required or the maximal support time of 28 days is reached, the device is weaned and removed. Subjects will be followed to 90 days post-implant.