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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 : November 16, 2022
Sponsor:
Information provided by (Responsible Party):
Evaheart, Inc.

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Heart Failure Device: EVAHEART Left Ventricular Assist System (LVAS) Device: HeartMate 3 Not Applicable

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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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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 III with dyspnea upon mild physical activity or Class IV heart failure.
 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 (HM3)
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Change in KCCQ and EuroQol [ Time Frame: Baseline versus POD 30, 90, 180, 360 and every 180 days ]
  2. Change in 6-minute walk test [ Time Frame: Baseline versus POD 30, 90, 180, 360 and every 180 days ]
  3. NYHA functional class [ Time Frame: Baseline versus POD 30, 90, 180, 360, and every 180 days ]
  4. Frequency and incidence of all re-operations [ Time Frame: Discharge after implant through transplant or explant for recovery. ]
  5. Frequency and incidence of all rehospitalizations [ Time Frame: Discharge after implant through transplant or explant for recovery. ]
  6. 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).


  7. 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) ]
  8. Post-transplant or post-explant survival [ Time Frame: Up to 30 days post-transplant or post-explant ]

Other Outcome Measures:
  1. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy
  2. Technical obstacles which pose an inordinately high surgical risk
  3. Existence of ongoing mechanical circulatory support (MCS) other than IABP and Impella 5.0 or 5.5
  4. Ongoing Impella (5.0 or 5.5) presenting related clinical sign (i.e. hematuria) and elevated LDH equal or greater than 600 IU/L.
  5. Positive pregnancy test if of childbearing potential
  6. Presence of mechanical aortic cardiac valve that will not be either converted to a bioprosthesis
  7. History of any organ transplant
  8. Platelet count <100,000/mL
  9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues
  10. History of confirmed, untreated abdominal aortic aneurysm (AAA) > 5 cm in diameter within 6 months of enrollment
  11. Presence of an active, uncontrolled infection
  12. Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy that the investigator will require based upon the patient's health status
  13. Presence of remarkable pre-defined end-organ dysfunction.
  14. Patient has moderate to severe aortic insufficiency without plans for correction during pump implant
  15. Low albumin - removed from recent exclusion criteria
  16. Planned Bi-VAD support prior to enrollment
  17. Patient has known hypo- or hyper coagulable state such as disseminated intravascular coagulation and heparin induced thrombocytopenia (HIT)
  18. Participation in any other clinical investigation that is likely to confound study results or affect the study
  19. Any condition other than heart failure that could limit survival to less than 24 months
  20. Patients refusing blood transfusion
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Lizatte Martinez 713-520-7979 ext 2 lmartinez@evaheart-usa.com
Contact: Maricar Cruz 713-520-7979 ext 1 maricar@evaheart-usa.com

Locations
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United States, Florida
UF Health Shands Hospital Recruiting
Gainesville, Florida, United States, 32608
Contact: Janette "Nicole" Bostick    352-273-8938    Janette.Bostick@medicine.ufl.edu   
Principal Investigator: Mustafa Ahmed, MD         
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, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Gaurav Das, MBChB, MPH    617-636-4990    gdas@tuftsmedicalcenter.org   
Principal Investigator: Michael Kiernan, MD         
United States, North Carolina
Atrium Health Sanger Heart and Vascular Institute Active, not recruiting
Charlotte, North Carolina, United States, 28203
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Susan Reilly, RN,BSN,CCRC    513-585-1777    Susan.Reilly@thechristhospital.com   
Contact: Linda Pennington    513-585-1777      
Principal Investigator: Gregory Egnaczyk, MD         
United States, Pennsylvania
Penn State Health Milton S Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Katie Loffredo, RN,BSN,CCRC    717-531-6855    kloffredo@pennstatehealth.psu.edu   
Contact: Heather Reesor, RN,BSN,CMSRN    717-531-1452    hreesor@pennstatehealth.psu.edu   
Principal Investigator: Robert Dowling, MD         
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Patricia McNelis, CNMT, CCRP    267-541-0813    patricia.mcnelis@tuhs.temple.edu   
Contact: Jennie Wong, RN, CCRP    215-707-0061    Jennie.Wong@tuhs.temple.edu   
Principal Investigator: Yoshiya Toyoda, MD         
United States, Texas
Baylor Scott and White, Dallas Recruiting
Dallas, Texas, United States, 75246
Contact: Kiersten Schneider, RN    214-818-7638    kiersten.schneider@bswhealth.org   
Principal Investigator: Dan Meyer, MD         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Melissa Munoz-Beilis    713-798-8179    beilis@bcm.edu   
Contact: Susana Lopez-Alamillo    713-798-2883    susana.lopezalamillo@bcm.edu   
Principal Investigator: Alexis Shafii, MD         
Methodist Hospital - San Antonio Active, not recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia Medical Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Ashley Fox    434-987-1388    atf4c@hscmail.mcc.virginia.edu   
Contact: Elizabeth Lucas, RN, BSN    434-327-8698    eml6f@hscmail.mcc.virginia.edu   
Principal Investigator: Leora Yarboro, MD         
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Kent Shively    206-598-3696    raackek@uw.edu   
Principal Investigator: Claudius Mahr, DO         
United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53792
Contact: Amelia Stranz, MS    608-262-0299    stranz@surgery.wisc.edu   
Contact    608-576-0788    surgeryresearch@surgery.wisc.edu   
Principal Investigator: Ravi Dhingra, MD         
Sponsors and Collaborators
Evaheart, Inc.
Investigators
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Study Director: Tadashi Motomura, MD, PhD Evaheart, Inc.
More Information
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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: November 16, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Evaheart, Inc.:
Heart failure
LVAS
LVAD
 Bridge-to-transplant
Continuous flow pump
Destination therapy
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases