Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System (COMPETENCE)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, LVAS, LVAD, Bridge-to-transplant, Continuous flow pump, Destination therapy
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Sites / Locations
- UF Health Shands HospitalRecruiting
- Jackson Health Systems Jackson Memorial Hospital Lbn Public Health Trust of Miami Dade County Florida
- Tampa General HospitalRecruiting
- St. Vincent Hospital IndianapolisRecruiting
- University of LouisvilleRecruiting
- Tufts Medical CenterRecruiting
- Atrium Health Sanger Heart and Vascular InstituteRecruiting
- The Christ HospitalRecruiting
- Penn State Health Milton S Hershey Medical CenterRecruiting
- Temple UniversityRecruiting
- Baylor Scott and White, DallasRecruiting
- Baylor College of MedicineRecruiting
- Methodist Hospital - San Antonio
- University of Virginia Medical CenterRecruiting
- University of Washington Medical Center
- University of Wisconsin-MadisonRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Evaheart LVAS (EVA2)
HeartMate 3 (HM3)
The objective of the study is to evaluate the safety and effectiveness of the EVA2 by demonstrating non-inferiority to commercially approved LVADs when used for the treatment of refractory NYHA Class III with dyspnea upon mild physical activity or Class IV heart failure.
The objective of the study is to evaluate the safety and effectiveness of the EVA2 by demonstrating non-inferiority to commercially approved LVADs when used for the treatment of refractory NYHA Class III with dyspnea upon mild physical activity or Class IV heart failure.