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).
Adult (>18 years old), advanced heart failure NYHA Class III with dyspnea upon mild physical activity or Class IV patients who are refractory to advanced heart failure management and meet study Inclusion/Exclusion criteria will be enrolled.
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 advanced heart failure.
Subjects will be followed for 6 months (short-term cohort) and 24 months (long-term cohort) after EVA2/HM3 LVAS implantation or until outcome events of transplantation, explantation, death or withdrawal, whichever occurs first. Whereas subjects experiencing the outcome events of "Severe RHF" and "Disabling stroke" will remain in study follow-up.
|Full study title||Prospective Multi-Center Randomized Study for Evaluating the EVAHEART?2 Left Ventricular Assist System: the COMPETENCE Trial (COMPETENCE)|
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
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 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
- Patients refusing blood transfusion
Mustafa M Ahmed, MDAdvanced Heart Failure and Transplant Specialist, Cardiologist (Heart Specialist)
Participate in a study
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Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contactMustafa Ahmed
Get screened to confirm eligibility
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If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.