COMPETENCE Trial: The EVAHEART 2 continuous flow left ventricular assist device

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Devices

Background:

• Continuous flow left ventricular assist devices (LVAS) improve outcomes for end-stage heart failure.
• Existing LVAS have adverse event profiles limiting widespread use.
• The EVAHEART®2 (EVA2) LVAS features large blood gaps and a non-protruding inflow cannula to potentially mitigate adverse events.

Purpose of the Study:

• To assess the non-inferiority of the EVA2 LVAS compared to the HeartMate 3 LVAS (HM3) in patients with refractory advanced heart failure.
• To evaluate the safety and efficacy of the EVA2 LVAS in mechanical circulatory support.

Main Methods:

• A prospective, multi-center, randomized non-inferiority study (COMPETENCE Trial).
• Primary endpoint: composite of survival to transplant/explant, freedom from disabling stroke, and freedom from severe right heart failure.
• Randomization ratio of 2:1 (EVA2:HM3).

Main Results:

• The first patient was enrolled in December 2020.
• Currently, 25 subjects are enrolled (16 EVA2, 9 HM3).
• Enrollment for the safety cohort is expected by Q3 2022, with an interim analysis planned.

Conclusions:

• The EVA2's design, including its inflow cannula and large blood gaps, may enhance clinical outcomes.
• The ongoing COMPETENCE trial will determine if the EVA2 is non-inferior to the HM3 LVAS.
• Further studies are needed to fully understand the clinical benefits of the EVA2.