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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 : January 5, 2021
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 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 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 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
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


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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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) ≤ 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
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: Claire Huang, PhD 7135207979 ext 2 chuang@evaheart-usa.com

Locations
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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         
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: January 5, 2021
Last Verified: January 2021

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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
rotary pump
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases