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.
EVAHEART COMPETENCE
Prospective Multi-Center Randomized Study for Evaluating the EVAHEART2 Left Ventricular Assist System: the COMPETENCE Trial
Heart failure
All genders
18+
Recruiting now
Overview
Principal Investigator: Dr. Michael Kiernan
Contact Us
Laura Telfer
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.