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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
COMPETENCE Trial 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.
COMPETENCE Trial 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.
Select...
I am 18 years old or older.
COMPETENCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
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 moreOther outcome measures
Powered Secondary Endpoint: GI bleeding
COMPETENCE 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.
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still available slots for prospective participants in this research trial?
"According to the available data on clinicaltrials.gov, this medical investigation is presently open for patient enrolment. This project was initially published on March 31st 2020 and has been revised most recently November 15th 2022."
Answered by AI
What is the upper limit to the number of participants included in this clinical investigation?
"Yes, the details posted on clinicaltrials.gov demonstrate that this medical study is currently recruiting participants. This trial was first published on March 31st 2020 and most recently modified on November 15th 2022; these researchers aim to enrol 399 individuals across 12 different sites."
Answered by AI
Are there various locations conducting this experiment in the state?
"Presently, the trial is enrolling patients at 12 research sites located in Gainesville, Dallas and Seattle among other urban centres. To minimize travel needs when participating, it may be prudent to choose the closest clinic available."
Answered by AI
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