EVAHEART®2 LVAS for Heart Failure

(COMPETENCE Trial)

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Evaheart, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a prospective, multi-center, unblinded, randomized, controlled, and non-inferiority study comparing the EVA2 LVAS to the most recent magnetically levitated centrifugal LVAS (HM3 LVAS).

Research Team

Tadashi Motomura, MD, PhD

Principal Investigator

Evaheart, Inc.

Eligibility Criteria

This trial is for adults over 18 with severe heart failure (NYHA Class III/IV), an ejection fraction below 30%, and either dependent on specific heart medications or with a low cardiac index. Excluded are those with organ transplants, active infections, participation in other trials, certain types of heart failure, high surgical risks, ongoing mechanical circulatory support issues, untreated large abdominal aortic aneurysms, blood disorders including refusal of transfusions or intolerance to anticoagulants/antiplatelets.

Inclusion Criteria

Your heart's pumping ability is very low, less than 30%.

I need medication to support my heart's pumping action or my heart pumps less blood than it should without medication.

More detailed inclusion criteria information is noted in the study protocol

Exclusion Criteria

I am using an Impella device and have symptoms like blood in urine and high LDH levels.

Your blood platelet count is less than 100,000 per milliliter.

I have health issues that make surgery very risky for me.

Treatment Details

Interventions

• EVAHEART®2 Left Ventricular Assist System (Left Ventricular Assist System)
• HeartMate 3 (Left Ventricular Assist System)

Trial Overview The study compares two devices designed to assist the left ventricle of the heart: EVAHEART®2 LVAS and HeartMate 3. It's randomized and controlled to see if EVAHEART®2 is not inferior to HeartMate 3 in patients needing such assistance due to advanced heart failure.

Participant Groups

Group I: Evaheart LVAS (EVA2) Experimental Treatment 1 Intervention

The objective of the study is to evaluate the safety and effectiveness of the EVA2 by demonstrating non-inferiority to commercially approved LVADs when used for the treatment of refractory NYHA Class III with dyspnea upon mild physical activity or Class IV heart failure.

Group II: HeartMate 3 (HM3) Active Control 1 Intervention

The objective of the study is to evaluate the safety and effectiveness of the EVA2 by demonstrating non-inferiority to commercially approved LVADs when used for the treatment of refractory NYHA Class III with dyspnea upon mild physical activity or Class IV heart failure.

Who Is Running the Clinical Trial?

Evaheart, Inc.

Lead Sponsor

Trials

1

Recruited

400+