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EVAHEART COMPETENCE

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
ltelfer@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT01187368

Overview

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.