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Left Ventricular Assist System
EVAHEART®2 LVAS for Heart Failure (COMPETENCE Trial)
Dallas, TX
N/A
Waitlist Available
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
No Placebo-Only Group
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.
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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 belowSelect...
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.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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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Select...
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.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Long-Term Primary Endpoint
Short-Term Primary Endpoint
Secondary study objectives
Incidence of adverse events, serious adverse events and UADEs
Other study objectives
Powered Secondary Endpoint: GI bleeding
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Closest Location:Baylor Scott and White, Dallas· Dallas, TX
Who is running the clinical trial?
Evaheart, Inc.Lead Sponsor
Tadashi Motomura, MD, PhDStudy DirectorEvaheart, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You are currently using a mechanical circulatory support device, except for IABP, Impella 5.0, or 5.5.I have an untreated large abdominal aortic aneurysm diagnosed within the last 6 months.I currently have an infection that is not under control.You are scheduled to receive Bi-VAD support before joining the study.Your heart's pumping ability is very low, less than 30%.I have a mechanical aortic valve that won't be changed to a biological one.My heart failure is not caused by untreated thyroid disease or specific heart muscle conditions.I cannot tolerate blood thinners or certain medications after surgery as per my doctor's advice.My organs are not working properly due to my condition.I have a serious heart valve issue not planned to be fixed during my pump implant.I have a blood clotting disorder like DIC or HIT.I refuse to receive blood transfusions.I need medication to support my heart's pumping action or my heart pumps less blood than it should without medication.I have had an organ transplant.You have a mental health condition, permanent memory problems, or social issues that could affect your participation.I get short of breath with light activity or cannot do any activity due to heart failure.I am 18 years old or older.I do not have any health conditions that could shorten my life to under 2 years, aside from heart failure.If you could become pregnant, you have a positive pregnancy test.
Research Study Groups:
This trial has the following groups:- Group 1: HeartMate 3 (HM3)
- Group 2: Evaheart LVAS (EVA2)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.