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Title Prospective Multi-Center Randomized Study for Evaluating the EVAHEART2 Left Ventricular Assist System: the COMPETENCE Trial
Therapeutic Area Heart Failure
Principal Investigator Dr. Michael Kiernan
Min Age 18 Years
Gender All
Contact Laura Telfer
617 636 4904
More Information


The purpose of this randomized study is to evaluate the safety and effectiveness of EVAHEART 2 Implantable Left Ventricular Assist System (EVA2 LVAS) by demonstrating non-inferiority to HeartMate 3 when used for the treatment of advanced, refractory, New York Heart Association Class IV heart failure.

Study Details

Inclusion Criteria

  • NYHA IV 2. LVEF greater or equal to 25% 3. Other hemodynamic parameter and mechanical circulatory assist devices

Exclusion Criteria

  • Heart failure associated with thyroid disease, obstructive cardiomyopathy, pericardial diseases, amyloidosis, or restrictive cardiomyopathy 2. Existence of ongoing mechanical circulatory support other than IABP and Impella 5.0/5.5 3. Technical difficulties, which may impact increased surgical risk and clinical outcomes

Study Requirements

Questionnaires, ECHOs, 6-minute walk tests, physical exams, vital signs, and hemodynamic measures will be assessed at baseline, implant, 1 month, 3, months, and 6 months post-implant, then every 6 months up to 5 years. VO2 measurements will be taken at baseline and 6 months post-implant. Chest x-rays will be performed prior to the implant and at discharge. 1.5 tablespoons of blood will be drawn at each visit.