The COMPETENCE Trial: Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System

• Published in: The Journal of heart and lung transplantation Vol. 41; no. 4; p. S25
• Main Authors: Slaughter, M., Meyer, D., Ravichandran, A., Ono, M., Dowling, R., Yarboro, L., Ahmed, M., Kiernan, M., Mahr, C., Shafii, A., Dhingra, R., Smith, J.
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.04.2022
• ISSN: 1053-2498; 1557-3117
• DOI: 10.1016/j.healun.2022.01.053

LVADs have demonstrated improved survival and quality of life for patients with end-stage heart failure. However, adverse events have limited the growth and use of LVADs. The EVAHEART 2 LVAD has new design features to potentially reduce adverse events related to the inflow cannula, right heart failure and blood trauma. The COMPETENCE Trial is a prospective, multi-center, randomized non-inferiority trial comparing the EVAHEART 2 to the HeartMate 3 LVAD. Patients are randomized 2:1 (EVA2:HM3) and will enter the “short term” cohort for the initial 6 months and continue to be evaluated for up to 24 months as a “long term” cohort. The “short term” cohort will consist of 138 subjects and the “long term” 399 subjects. An initial Safety Phase of 15 randomized subjects will have 6 month data reviewed prior to proceeding with enrolling the entire “short term” cohort in the Expanded Phase. There are 11 active sites and 11 subjects have been enrolled: 8 EVA2 and 3 HM3. Trial updates and data as allowed for the study design will be reported.