The HeartMate II® Left Ventricular Assist System Pivotal Study – Destination Therapy

The Destination Therapy (DT) arm of the HeartMate II LVAS study is open to patients who are not heart transplant candidate. The purpose of this study is to compare the HeartMate II to the HeartMate XVE device to see if it can provide the same or better support as the XVE. While both are left ventricle assist device, the HeartMate XVE is larger and operates on different principles than the HeartMate II. The HeartMate II is a smaller device and is a continuous flow pump that utilizes an electric rotary to propel blood from the left ventricle to the rest of the body. Unlike the HeartMate XVE, the HeartMate II requires anticoagulation. To be eligible for this study, patients must provide consent and meet specific study criteria.

Dzifa Dordunoo, MSN, RN
Email: edordun1@jhmi.edu
(410) 955-3597

Tamara Bubb, BS
Email: tbubb1@jhmi.edu
(410) 502-5438

The HeartMate II LVAS Pivotal Study (Destination Therapy)

2004 0056

Inclusions:?

• 18 years old or older
• Patient with advanced heart failure symptoms (Class IIIB or IV)
• Patient ineligible for transplant
• Patient with EF less than 25%

Exclusions:

• Etiology of heart failure is due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy.
• Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator.
• Existence of any ongoing mechanical circulatory support.
• Positive pregnancy test if female of childbearing age.
• Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAD management.
• Intolerance to anticoagulant or antiplatelet therapies or any other peri/post operative therapy the investigator will require based upon the patient's health status.