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Study for Evaluating the EVAHEART?2 LVAS: the COMPETENCE Trial (COMPETENCE)

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
  • Healthy Volunteers


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)
Protocol number OCR35862 ID NCT01187368
Phase N/A


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:

  1. Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy

  2. Technical obstacles which pose an inordinately high surgical risk

  3. Existence of ongoing mechanical circulatory support (MCS) other than IABP and Impella 5.0 or 5.5

  4. Ongoing Impella (5. 0 or 5. 5. presenting related clinical sign (i.e. hematuria) and elevated LDH equal or greater than 600 IU/L.

  5. Positive pregnancy test if of childbearing potential

  6. Presence of mechanical aortic cardiac valve that will not be either converted to a bioprosthesis

  7. History of any organ transplant

  8. Platelet count 5 cm in diameter within 6 months of enrollment

  9. Presence of an active, uncontrolled infection

  10. Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative

therapy that the investigator will require based upon the patient's health status

  1. Presence of remarkable pre-defined end-organ dysfunction.

  2. Patient has moderate to severe aortic insufficiency without plans for correction

during pump implant

  1. Low albumin * removed from recent exclusion criteria

  2. Planned Bi-VAD support prior to enrollment

  3. Patient has known hypo* or hyper coagulable state such as disseminated intravascular

coagulation and heparin induced thrombocytopenia (HIT)

  1. Participation in any other clinical investigation that is likely to confound study

results or affect the study

  1. Any condition other than heart failure that could limit survival to less than 24


  1. Patients refusing blood transfusion

Lead researcher

  • Advanced Heart Failure and Transplant Specialist, Cardiologist (Heart Specialist)
    Mustafa M Ahmed

Participate in a study

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  1. Step

    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 contact

  2. Step

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step


    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.