Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System (COMPETENCE)
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ClinicalTrials.gov Identifier: NCT01187368 |
Recruitment Status :
Recruiting
First Posted : August 24, 2010
Last Update Posted : January 5, 2021
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Condition or disease | Intervention/treatment | Phase |
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Heart Failure | Device: EVAHEART Left Ventricular Assist System (LVAS) Device: HeartMate 3 | Not Applicable |
Adult (>18 years old), advanced heart failure NYHA 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 NYHA Class IV 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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 399 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Intervention 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) |
Primary Purpose: | Treatment |
Official Title: | Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System: the COMPETENCE Trial |
Actual Study Start Date : | March 31, 2020 |
Estimated Primary Completion Date : | March 31, 2023 |
Estimated Study Completion Date : | March 31, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Evaheart LVAS (EVA2)
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 IV heart failure.
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Device: EVAHEART Left Ventricular Assist System (LVAS)
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.
Other Name: EVA2 |
Active Comparator: HeartMate 3
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 IV heart failure.
|
Device: HeartMate 3
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.
Other Name: HM3 |
- 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
- 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) ]
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).
- 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 ]
- Powered Secondary Endpoint: GI bleeding [ Time Frame: 24 months ]
Documented mucosal (GI tract and/or nasopharynx) bleeding, requiring blood transfusion (backed red blood cells) or hemoglobin drop (>2 g/dL) without another identifiable source of bleeding AND meet one or more of the following:
- Identified mucosal bleeding by endoscope
- Appearance of overt melena, hematochezia, hematemesis, epistaxis
- Occult bleeding as evidenced by hemoccult-positive stool (2 consecutive testing to avoid false positive)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following is a list of general inclusion criteria:
- Age ≥ 18 years
- Left Ventricular Ejection Fraction (LVEF) ≤ 25%
- NYHA Class IV heart failure
- Patient is able to provide written informed consent
- More detailed inclusion criteria information is noted in the study protocol
Exclusion Criteria:
The following is a list of general exclusion criteria:
- Active, uncontrolled infection
- Severe end organ dysfunction or failure
- History of any organ transplant
- Prosthetic mechanical aortic valve that will not be converted to a bioprosthesis
- Patients with an unacceptable risk for successful LVAD implantation and maintenance
- Patients refusing blood transfusion
- Intolerant of anticoagulation therapy
- Active psychiatric disorder, irreversible cognitive dysfunction or other psychosocial behavior that impairs the ability of the patient to follow instructions, maintain their device or their medical regimen
- Pregnancy
- Current dependence on other mechanical circulatory support device at the time of implant, other than IABP and Impella 5.0/5.5
- Presence of condition other than heart failure that would limit survival to less than 24 months
- More detailed exclusion criteria information is noted in the study protocol

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187368
Contact: Claire Huang, PhD | 7135207979 ext 2 | chuang@evaheart-usa.com |
United States, Indiana | |
St. Vincent Hospital Indianapolis | Recruiting |
Indianapolis, Indiana, United States, 46260 | |
Contact: Regina Margiotti 317-338-6151 regina.margiotti@ascension.org | |
Principal Investigator: Ashwin Ravichandran, MD | |
United States, Kentucky | |
University of Louisville | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Terry Blanton, RN 502-587-4381 mary.blanton@louisville.edu | |
Principal Investigator: Mark Slaughter, MD | |
United States, Pennsylvania | |
Penn State Health Milton S Hershey Medical Center | Recruiting |
Hershey, Pennsylvania, United States, 17033 | |
Contact: Katie Loffredo 717-531-6855 kloffredo@pennstatehealth.psu.edu | |
Principal Investigator: Robert Dowling, MD | |
United States, Texas | |
Baylor Scott and White, Dallas | Recruiting |
Dallas, Texas, United States, 75246 | |
Contact: Roberta Olson, RN 214-818-2588 Roberta.Olson@BSWHealth.org | |
Principal Investigator: Dan Meyer, MD | |
Baylor College of Medicine | Not yet recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Alexis Shafii, MD | |
Methodist Hospital - San Antonio | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Gloria Carreon, RN, CCRC 210-575-3064 Gloria.Carreon@MHShealth.com | |
Principal Investigator: Masahiro Ono, MD | |
United States, Wisconsin | |
University of Wisconsin-Madison | Not yet recruiting |
Madison, Wisconsin, United States, 53792 | |
Contact: Lekha Nelavelli 608-262-9383 nelavelli@surgery.wisc.edu | |
Principal Investigator: Jason Smith, MD |
Study Director: | Tadashi Motomura, MD, PhD | Evaheart, Inc. |
Responsible Party: | Evaheart, Inc. |
ClinicalTrials.gov Identifier: | NCT01187368 |
Other Study ID Numbers: |
020-1601-001-P01 |
First Posted: | August 24, 2010 Key Record Dates |
Last Update Posted: | January 5, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
heart failure LVAS LVAD bridge-to-transplant rotary pump |
Heart Failure Heart Diseases Cardiovascular Diseases |