Heart FailureCOMPETENCENCT01187368
Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System
A study testing EVAHEART Left Ventricular Assist System (LVAS) and HeartMate 3 in people with Heart Failure, run by Evaheart, Inc. at 12 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- EVAHEART Left Ventricular Assist System (LVAS) and HeartMate 3
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 12 sitesUnited States
- Study dates
- 31 Mar 2020to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The following is a list of general inclusion criteria:
- Age ≥ 18 years
- Left Ventricular Ejection Fraction (LVEF) < 30%
- NYHA Class III with dyspnea upon mild physical activity or Class IV heart failure
- Inotrope dependent OR Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes
- Patient is able to provide written informed consent
- More detailed inclusion criteria information is noted in the study protocol
Who cannot join
- Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy
- Technical obstacles which pose an inordinately high surgical risk
- Existence of ongoing mechanical circulatory support (MCS) other than IABP and Impella 5.0 or 5.5
- Ongoing Impella (5.0 or 5.5) presenting related clinical sign (i.e. hematuria) and elevated LDH equal or greater than 600 IU/L.
- Positive pregnancy test if of childbearing potential
- Presence of mechanical aortic cardiac valve that will not be either converted to a bioprosthesis
Show all 20Show fewer
- History of any organ transplant
- Platelet count <100,000/mL
- Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues
- History of confirmed, untreated abdominal aortic aneurysm (AAA) > 5 cm in diameter within 6 months of enrollment
- Presence of an active, uncontrolled infection
- Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy that the investigator will require based upon the patient's health status
- Presence of remarkable pre-defined end-organ dysfunction.
- Patient has moderate to severe aortic insufficiency without plans for correction during pump implant
- Low albumin - removed from recent exclusion criteria
- Planned Bi-VAD support prior to enrollment
- Patient has known hypo- or hyper coagulable state such as disseminated intravascular coagulation and heparin induced thrombocytopenia (HIT)
- Participation in any other clinical investigation that is likely to confound study results or affect the study
- Any condition other than heart failure that could limit survival to less than 24 months
- Patients refusing blood transfusion
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Tufts Medical Center
Boston, Massachusetts, 02111
University of Virginia Medical Center
Charlottesville, Virginia, 22908
The Christ Hospital
Cincinnati, Ohio, 45219
Baylor Scott and White, Dallas
Dallas, Texas, 75246
UF Health Shands Hospital
Gainesville, Florida, 32608
Penn State Health Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
St. Vincent Hospital Indianapolis
Indianapolis, Indiana, 46260
University of Louisville
Louisville, Kentucky, 40202
University of Wisconsin-Madison
Madison, Wisconsin, 53792
Methodist Hospital - San Antonio
San Antonio, Texas, 78229
Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System: the COMPETENCE 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).
Read the detailed description
Adult (>18 years old), advanced heart failure NYHA Class III with dyspnea upon mild physical activity or Class IV patients who are refractory to advanced heart failure management and meet study Inclusion/Exclusion criteria will be enrolled.
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 advanced heart failure.
Subjects will be followed for 6 months (short-term cohort) and 24 months (long-term cohort) after EVA2/HM3 LVAS implantation or until outcome events of transplantation, explantation, death or withdrawal, whichever occurs first. Whereas subjects experiencing the outcome events of "Severe RHF" and "Disabling stroke" will remain in study follow-up.
- Conditions
- Heart Failure
- Being tested
- EVAHEART Left Ventricular Assist System (LVAS), HeartMate 3
- Keywords
- Heart failure, LVAS, LVAD, Bridge-to-transplant, Continuous flow pump, Destination therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVAHEART Left Ventricular Assist System (LVAS)Device
Also called EVA2
Three-hundred and ninety-nine (399) subjects will be enrolled and randomized in a 2:1 assignment to receive EVA2 or the comparator device, HeartMate 3.
HeartMate 3Device
Also called HM3
Three-hundred and ninety-nine (399) subjects will be enrolled and randomized in a 2:1 assignment to receive EVA2 or the comparator device, HeartMate 3.
| Study group | Role | What they receive |
|---|---|---|
| Evaheart LVAS (EVA2) | Experimental | 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. Receives: Device: EVAHEART Left Ventricular Assist System (LVAS) |
| HeartMate 3 (HM3) | Active comparator | 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. Receives: Device: HeartMate 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-Term Primary Endpoint
Survival to cardiac transplant or device explant for recovery free from disabling stroke (Modified Rankin Score > 3) or pre-defined severe Right Heart Failure at 6 months after implantation of the originally implanted device
Measured: 6 months
Long-Term Primary Endpoint
Survival to cardiac transplant or device explant for recovery free from disabling stroke (Modified Rankin Score > 3) or pre-defined severe Right Heart Failure at 24 months after implantation of the originally implanted device
Measured: 24 months
Secondary outcomes (8)
Change in KCCQ and EuroQol
Measured: Baseline versus POD 30, 90, 180, 360 and every 180 days
Change in 6-minute walk test
Measured: Baseline versus POD 30, 90, 180, 360 and every 180 days
NYHA functional class
Measured: Baseline versus POD 30, 90, 180, 360, and every 180 days
Frequency and incidence of all re-operations
Measured: Discharge after implant through transplant or explant for recovery.
Frequency and incidence of all rehospitalizations
Measured: Discharge after implant through transplant or explant for recovery.
Incidence of adverse events, serious adverse events and UADEs
Peri-operative complications and any failure to successfully implant the device.
All adverse events occurring during the acute and chronic phase of the study (frequency, severity, duration, sequelae and relationship to device).
All adverse events occurring during the extension phase (frequency, severity, duration, sequelae and relationship to device).
Measured: Implant through transplant or explant for recovery (+60 days or discharge) or 180 days on device; then duration of device support, up to 360 days (approximate)
Incidence of all device failures and device malfunctions
Measured: Implant through transplant or explant for recovery (+60 days or discharge) or 180 days on device; then duration of device support, up to 360 days(approximate)
Post-transplant or post-explant survival
Measured: Up to 30 days post-transplant or post-explant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study start31 Mar 2020
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Why it stopped: Subject recruitment is temporarily on hold due to ongoing device modification.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Three-hundred and ninety-nine (399) subjects will be enrolled and randomized in a 2:1 assignment to receive EVA2 or the comparator device, HeartMate 3.
- Masking
- None (open label)
- Enrolment
- 399 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evaheart, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tadashi Motomura, MD, PhD, Study director, Evaheart, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187368
- Sponsor's protocol ID
- 020-1601-001-P01
- Acronym
- COMPETENCE
- Status last verified
- Mar 2026
- First submitted
- 19 Aug 2010
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Dual SA, Cowger J, Roche E, Nayak A. The Future of Durable Mechanical Circulatory Support: Emerging Technological Innovations and Considerations to Enable Evolution of the Field. J Card Fail. 2024 Apr;30(4):596-609. doi: 10.1016/j.cardfail.2024.01.011. Epub 2024 Feb 29.
PubMed 38431185
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System: the COMPETENCE Trial
- ClinicalTrials.gov ID
- NCT01187368
- Acronym / sponsor ID
- COMPETENCE / 020-1601-001-P01
- Conditions
- Heart Failure
- Keywords
- Heart failure, LVAS, LVAD, Bridge-to-transplant, Continuous flow pump, Destination therapy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Subject recruitment is temporarily on hold due to ongoing device modification.
- Enrolment
- 399 participants (estimated)
- Lead sponsor
- Evaheart, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 24 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Adult (>18 years old), advanced heart failure NYHA Class III with dyspnea upon mild physical activity or Class IV patients who are refractory to advanced heart failure management and meet study Inclusion/Exclusion criteria will be enrolled.
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 advanced heart failure.
Subjects will be followed for 6 months (short-term cohort) and 24 months (long-term cohort) after EVA2/HM3 LVAS implantation or until outcome events of transplantation, explantation, death or withdrawal, whichever occurs first. Whereas subjects experiencing the outcome events of "Severe RHF" and "Disabling stroke" will remain in study follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Three-hundred and ninety-nine (399) subjects will be enrolled and randomized in a 2:1 assignment to receive EVA2 or the comparator device, HeartMate 3.
| Arm | Type | Receives |
|---|---|---|
| Evaheart LVAS (EVA2) | Experimental | Device: EVAHEART Left Ventricular Assist System (LVAS)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. |
| HeartMate 3 (HM3) | Active comparator | Device: HeartMate 3The 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Left Ventricular Ejection Fraction (LVEF) < 30%
- NYHA Class III with dyspnea upon mild physical activity or Class IV heart failure
- Inotrope dependent OR Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes
- Patient is able to provide written informed consent
Key exclusion criteria (20 listed)
- Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy
- Technical obstacles which pose an inordinately high surgical risk
- Existence of ongoing mechanical circulatory support (MCS) other than IABP and Impella 5.0 or 5.5
- Ongoing Impella (5.0 or 5.5) presenting related clinical sign (i.e. hematuria) and elevated LDH equal or greater than 600 IU/L.
- Positive pregnancy test if of childbearing potential
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVAHEART Left Ventricular Assist System (LVAS)Also: EVA2Three-hundred and ninety-nine (399) subjects will be enrolled and randomized in a 2:1 assignment to receive EVA2 or the comparator device, HeartMate 3. | Device | Evaheart LVAS (EVA2) |
| HeartMate 3Also: HM3Three-hundred and ninety-nine (399) subjects will be enrolled and randomized in a 2:1 assignment to receive EVA2 or the comparator device, HeartMate 3. | Device | HeartMate 3 (HM3) |
Primary outcome
Short-Term Primary Endpoint
Time frame: 6 months
Survival to cardiac transplant or device explant for recovery free from disabling stroke (Modified Rankin Score > 3) or pre-defined severe Right Heart Failure at 6 months after implantation of the originally implanted device
Long-Term Primary Endpoint
Time frame: 24 months
Survival to cardiac transplant or device explant for recovery free from disabling stroke (Modified Rankin Score > 3) or pre-defined severe Right Heart Failure at 24 months after implantation of the originally implanted device
8 secondary outcomes
Change in KCCQ and EuroQol
Time frame: Baseline versus POD 30, 90, 180, 360 and every 180 days
Change in 6-minute walk test
Time frame: Baseline versus POD 30, 90, 180, 360 and every 180 days
NYHA functional class
Time frame: Baseline versus POD 30, 90, 180, 360, and every 180 days
Frequency and incidence of all re-operations
Time frame: Discharge after implant through transplant or explant for recovery.
Frequency and incidence of all rehospitalizations
Time frame: Discharge after implant through transplant or explant for recovery.
Incidence of adverse events, serious adverse events and UADEs
Time frame: Implant through transplant or explant for recovery (+60 days or discharge) or 180 days on device; then duration of device support, up to 360 days (approximate)
Incidence of all device failures and device malfunctions
Time frame: Implant through transplant or explant for recovery (+60 days or discharge) or 180 days on device; then duration of device support, up to 360 days(approximate)
Post-transplant or post-explant survival
Time frame: Up to 30 days post-transplant or post-explant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 38431185Dual SA, Cowger J, Roche E, Nayak A. The Future of Durable Mechanical Circulatory Support: Emerging Technological Innovations and Considerations to Enable Evolution of the Field. J Card Fail. 2024 Apr;30(4):596-609. doi: 10.1016/j.cardfail.2024.01.011. Epub 2024 Feb 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tadashi Motomura, MD, PhD study director
Evaheart, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVAHEART Left Ventricular Assist System (LVAS) and HeartMate 3 in people with Heart Failure, run by Evaheart, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-Term Primary Endpoint (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01187368, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.