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Left Ventricular Assist System

EVAHEART®2 LVAS for Heart Failure (COMPETENCE Trial)

N/A
Recruiting
Research Sponsored by Evaheart, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Inotrope dependent OR Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes
NYHA Class III with dyspnea upon mild physical activity or Class IV heart failure
Must not have
Ongoing Impella (5.0 or 5.5) presenting related clinical sign (i.e. hematuria) and elevated LDH equal or greater than 600 IU/L
History of confirmed, untreated abdominal aortic aneurysm (AAA) > 5 cm in diameter within 6 months of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Summary

This trial will compare the EVA2 LVAS to the most recent magnetically levitated centrifugal LVAS (HM3 LVAS) to see if it is non-inferior.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include bleeding complications due to necessary anticoagulant therapy post-implantation; risk of infection at the surgical site; possible device malfunction leading to inadequate circulation support; stroke risk associated with blood flow alteration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need medication to support my heart's pumping action or my heart pumps less blood than it should without medication.
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I get short of breath with light activity or cannot do any activity due to heart failure.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am using an Impella device and have symptoms like blood in urine and high LDH levels.
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I have an untreated large abdominal aortic aneurysm diagnosed within the last 6 months.
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I currently have an infection that is not under control.
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I have a mechanical aortic valve that won't be changed to a biological one.
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My heart failure is not caused by untreated thyroid disease or specific heart muscle conditions.
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My organs are not working properly due to my condition.
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I have a serious heart valve issue not planned to be fixed during my pump implant.
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I have a blood clotting disorder like DIC or HIT.
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I refuse to receive blood transfusions.
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I have had an organ transplant.
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I do not have any health conditions that could shorten my life to under 2 years, aside from heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Long-Term Primary Endpoint
Short-Term Primary Endpoint
Secondary outcome measures
Change in 6-minute walk test
Change in KCCQ and EuroQol
Frequency and incidence of all re-operations
+5 more
Other outcome measures
Powered Secondary Endpoint: GI bleeding

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Evaheart LVAS (EVA2)Experimental Treatment1 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 Control1 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.

Find a Location

Who is running the clinical trial?

Evaheart, Inc.Lead Sponsor
Tadashi Motomura, MD, PhDStudy DirectorEvaheart, Inc.

Media Library

EVAHEART®2 Left Ventricular Assist System (Left Ventricular Assist System) Clinical Trial Eligibility Overview. Trial Name: NCT01187368 — N/A
Heart Failure Research Study Groups: HeartMate 3 (HM3), Evaheart LVAS (EVA2)
Heart Failure Clinical Trial 2023: EVAHEART®2 Left Ventricular Assist System Highlights & Side Effects. Trial Name: NCT01187368 — N/A
EVAHEART®2 Left Ventricular Assist System (Left Ventricular Assist System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01187368 — N/A
~76 spots leftby Jul 2025
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