COMPETENCE Trial

 

Active Clinical Trial

The EVAHEART®2 LVAS (EVA2) is an investigational device currently undergoing a clinical trial approved by the FDA in North America. The trial, Prospective Randomized Multi-Center Evaluation of the EVAHEART®2 Left Ventricular System: The COMPETENCE trial aims to investigate the safety and effectiveness of the EVAHEART®2 in the treatment of refractory NYHA Class IV heart failure.

The COMPETENCE trial is a prospective, multi-center, unblinded, randomized control, non-inferiority study comparing the EVA2 (n=266) to Heartmate 3 (HM3) (n=133) in 399 subjects (full cohort). During the safety phase, a total of 15 randomized EVA2 patients will be evaluated at up to 10 centers, then expand up to a total of 40 centers. The primary endpoints for this study examine the composite of survival to transplant, recovery (device removal), or survival on the primary LVAD support free from (1) disabling stroke as defined by a Modified Rankin Scale > 3 and (2) severe right heart failure at 6 months (short-term cohort) and 24 months (long-term cohort). The secondary endpoints assess Quality of Life as measured by the EuroQoL 5D-5L and Kansas Cardiomyopathy Questionnaire, 6-minute walk test, rehospitalizations, re-operations, device malfunctions, and STS-INTERMACS defined adverse events. A sub-study including 70 patients (35 EVA2: 35 HM3) will examine Von Willebrand Factor degradation profiles. Primary inclusion criteria include the NYHA Class IV heart failure refractory to optimal medical management, adult (age≥18), Body Surface Area (BSA) ≥ 1.4 m2, left ventricular ejection fraction (LVEF) ≤ 25%, inotrope dependent, or a cardiac index (CI) < 2.2 L/min/m2 while not on inotrope. After the safety cohort, patients on Impella 5.0/5.5 can be eligible only when absence of pre-determined excessive hemolysis is confirmed. Patients on pre-operative ECMO and/or right ventricular assist device are not eligible.

For more information on the trial design, visit https://www.clinicaltrials.gov/study/NCT01187368.

 

What We’ve Achieved

No mechanical failure from durability testing in the last 10 years.

Regulatory approval was granted in Japan and has been used clinically in Japan since 2010.

A Total of 207 EVAHEART® have been implanted to-date as of 10/31/2021 in Japan: 142 EVA1 and 65 EVA2.