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Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System (COMPETENCE)

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EVAHEART Left Ventricular Assist System (LVAS)
HeartMate 3
Sponsored by
Evaheart, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, LVAS, LVAD, Bridge-to-transplant, Continuous flow pump, Destination therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UF Health Shands HospitalRecruiting
  • Jackson Health Systems Jackson Memorial Hospital Lbn Public Health Trust of Miami Dade County Florida
  • Tampa General HospitalRecruiting
  • St. Vincent Hospital IndianapolisRecruiting
  • University of LouisvilleRecruiting
  • Tufts Medical CenterRecruiting
  • Atrium Health Sanger Heart and Vascular InstituteRecruiting
  • The Christ HospitalRecruiting
  • Penn State Health Milton S Hershey Medical CenterRecruiting
  • Temple UniversityRecruiting
  • Baylor Scott and White, DallasRecruiting
  • Baylor College of MedicineRecruiting
  • Methodist Hospital - San Antonio
  • University of Virginia Medical CenterRecruiting
  • University of Washington Medical Center
  • University of Wisconsin-MadisonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Evaheart LVAS (EVA2)

HeartMate 3 (HM3)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Change in KCCQ and EuroQol
Change in 6-minute walk test
NYHA functional class
Frequency and incidence of all re-operations
Frequency and incidence of all rehospitalizations
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).
Incidence of all device failures and device malfunctions
Post-transplant or post-explant survival

Full Information

First Posted
August 19, 2010
Last Updated
March 20, 2023
Sponsor
Evaheart, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01187368
Brief Title
Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System
Acronym
COMPETENCE
Official Title
Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System: the COMPETENCE Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2020 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evaheart, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, LVAS, LVAD, Bridge-to-transplant, Continuous flow pump, Destination therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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)
Allocation
Randomized
Enrollment
399 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Evaheart LVAS (EVA2)
Arm Type
Experimental
Arm Description
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.
Arm Title
HeartMate 3 (HM3)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EVAHEART Left Ventricular Assist System (LVAS)
Other Intervention Name(s)
EVA2
Intervention 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.
Intervention Type
Device
Intervention Name(s)
HeartMate 3
Other Intervention Name(s)
HM3
Intervention 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.
Primary Outcome Measure Information:
Title
Short-Term Primary Endpoint
Description
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
Time Frame
6 months
Title
Long-Term Primary Endpoint
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change in KCCQ and EuroQol
Time Frame
Baseline versus POD 30, 90, 180, 360 and every 180 days
Title
Change in 6-minute walk test
Time Frame
Baseline versus POD 30, 90, 180, 360 and every 180 days
Title
NYHA functional class
Time Frame
Baseline versus POD 30, 90, 180, 360, and every 180 days
Title
Frequency and incidence of all re-operations
Time Frame
Discharge after implant through transplant or explant for recovery.
Title
Frequency and incidence of all rehospitalizations
Time Frame
Discharge after implant through transplant or explant for recovery.
Title
Incidence of adverse events, serious adverse events and UADEs
Description
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).
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)
Title
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)
Title
Post-transplant or post-explant survival
Time Frame
Up to 30 days post-transplant or post-explant
Other Pre-specified Outcome Measures:
Title
Powered Secondary Endpoint: GI bleeding
Description
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)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lizatte Martinez
Phone
713-520-7979
Ext
2
Email
lmartinez@evaheart-usa.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maricar Cruz
Phone
713-520-7979
Ext
1
Email
maricar@evaheart-usa.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tadashi Motomura, MD, PhD
Organizational Affiliation
Evaheart, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
UF Health Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janette "Nicole" Bostick
Phone
352-273-8938
Email
Janette.Bostick@medicine.ufl.edu
First Name & Middle Initial & Last Name & Degree
Mustafa Ahmed, MD
Facility Name
Jackson Health Systems Jackson Memorial Hospital Lbn Public Health Trust of Miami Dade County Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisset Moni
Email
ltueros@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Matthias Loebe, MD
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Nicholas, BS RN, CCRP
Phone
813-844-4914
Email
courtneynicholas@tgh.org
First Name & Middle Initial & Last Name & Degree
Lucian Lozonschi, MD
Facility Name
St. Vincent Hospital Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Margiotti
Phone
317-338-6151
Email
regina.margiotti@ascension.org
First Name & Middle Initial & Last Name & Degree
Ashwin Ravichandran, MD
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terry Blanton, RN
Phone
502-587-4381
Email
mary.blanton@louisville.edu
First Name & Middle Initial & Last Name & Degree
Mark Slaughter, MD
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaurav Das, MBChB, MPH
Phone
617-636-4990
Email
gdas@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
Easton Cummins
Phone
617 636-8417
Email
ecummins@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
Michael Kiernan, MD
Facility Name
Atrium Health Sanger Heart and Vascular Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krystal Winkler, CCRC
Phone
704-355-4794
Email
krystal.winkler@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Connie Dellinger, RN
Phone
704-355-4795
Email
connie.dellinger@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Sanjeev Gulati, MD
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Weber, RN, BSN
Phone
513-585-0038
Email
Michael.Weber@TheChristHospital.com
First Name & Middle Initial & Last Name & Degree
Linda Pennington
Phone
513-585-1777
Email
linda.pennington@thechristhospital.com
First Name & Middle Initial & Last Name & Degree
Gregory Egnaczyk, MD
Facility Name
Penn State Health Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Loffredo, RN,BSN,CCRC
Phone
717-531-6855
Email
kloffredo@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name & Degree
Heather Reesor, RN,BSN,CMSRN
Phone
717-531-1452
Email
hreesor@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name & Degree
Behzad Soleimani, MD
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia McNelis, CNMT, CCRP
Phone
267-541-0813
Email
patricia.mcnelis@tuhs.temple.edu
First Name & Middle Initial & Last Name & Degree
Jennie Wong, RN, CCRP
Phone
215-707-0061
Email
Jennie.Wong@tuhs.temple.edu
First Name & Middle Initial & Last Name & Degree
Yoshiya Toyoda, MD
Facility Name
Baylor Scott and White, Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiersten Schneider, RN
Phone
214-818-7638
Email
kiersten.schneider@bswhealth.org
First Name & Middle Initial & Last Name & Degree
Dan Meyer, MD
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Munoz-Beilis
Phone
713-798-8179
Email
beilis@bcm.edu
First Name & Middle Initial & Last Name & Degree
Susana Lopez-Alamillo
Phone
713-798-2883
Email
susana.lopezalamillo@bcm.edu
First Name & Middle Initial & Last Name & Degree
Alexis Shafii, MD
Facility Name
Methodist Hospital - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Fox
Phone
434-987-1388
Email
atf4c@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Robin Kelly, RN
Phone
434-262-9820
Email
rlk5a@uvahealth.org
First Name & Middle Initial & Last Name & Degree
Leora Yarboro, MD
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Shipe
Phone
608-263-3974
Email
shipe@surgery.wisc.edu
Phone
608-576-0788
Email
surgeryresearch@surgery.wisc.edu
First Name & Middle Initial & Last Name & Degree
Ravi Dhingra, MD

12. IPD Sharing Statement

Learn more about this trial

Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System

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