Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System

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Conditions studied: Heart Failure

In brief

This is a prospective, multi-center, unblinded, randomized, controlled, and non-inferiority study comparing the EVA2 LVAS to the most recent magnetically levitated centrifugal LVAS (HM3 LVAS).

Key facts

Study ID

NCT01187368

Run by

Evaheart, Inc.

People needed

399

Starts

2020-03-31

Expected to finish

2028-07-31

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The following is a list of general inclusion criteria:
• Age ≥ 18 years
• Left Ventricular Ejection Fraction (LVEF) < 30%
• NYHA Class III with dyspnea upon mild physical activity or Class IV heart failure
• Inotrope dependent OR Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes
• Patient is able to provide written informed consent
• More detailed inclusion criteria information is noted in the study protocol

You may not qualify if…

• Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy
• Technical obstacles which pose an inordinately high surgical risk
• Existence of ongoing mechanical circulatory support (MCS) other than IABP and Impella 5.0 or 5.5
• Ongoing Impella (5.0 or 5.5) presenting related clinical sign (i.e. hematuria) and elevated LDH equal or greater than 600 IU/L.
• Positive pregnancy test if of childbearing potential
• Presence of mechanical aortic cardiac valve that will not be either converted to a bioprosthesis
• History of any organ transplant
• Platelet count <100,000/mL
• Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues
• History of confirmed, untreated abdominal aortic aneurysm (AAA) > 5 cm in diameter within 6 months of enrollment
• Presence of an active, uncontrolled infection
• Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy that the investigator will require based upon the patient's health status
• Presence of remarkable pre-defined end-organ dysfunction.
• Patient has moderate to severe aortic insufficiency without plans for correction during pump implant
• Low albumin - removed from recent exclusion criteria
• Planned Bi-VAD support prior to enrollment
• Patient has known hypo- or hyper coagulable state such as disseminated intravascular coagulation and heparin induced thrombocytopenia (HIT)
• Participation in any other clinical investigation that is likely to confound study results or affect the study
• Any condition other than heart failure that could limit survival to less than 24 months
• Patients refusing blood transfusion

Where it is running

• UF Health Shands Hospital — Gainesville, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• St. Vincent Hospital Indianapolis — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• Penn State Health Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
• Baylor Scott and White, Dallas — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Methodist Hospital - San Antonio — San Antonio, Texas, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States
• University of Wisconsin-Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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