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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

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:

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

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.

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

NCT ID

NCT01187368

First Posted

August 19, 2010

Last Updated

March 20, 2023

Sponsor

Evaheart, Inc.

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

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

Arm Title

HeartMate 3 (HM3)

Arm Type

Active Comparator

Arm Description

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

Time Frame

6 months

Title

Long-Term Primary Endpoint

Description

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

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

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

lmartinez@evaheart-usa.com

First Name & Middle Initial & Last Name or Official Title & Degree

Maricar Cruz

Phone

713-520-7979

Ext

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

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

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

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

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

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

gdas@tuftsmedicalcenter.org

First Name & Middle Initial & Last Name & Degree

Easton Cummins

Phone

617 636-8417

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

krystal.winkler@atriumhealth.org

First Name & Middle Initial & Last Name & Degree

Connie Dellinger, RN

Phone

704-355-4795

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

Michael.Weber@TheChristHospital.com

First Name & Middle Initial & Last Name & Degree

Linda Pennington

Phone

513-585-1777

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

kloffredo@pennstatehealth.psu.edu

First Name & Middle Initial & Last Name & Degree

Heather Reesor, RN,BSN,CMSRN

Phone

717-531-1452

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

patricia.mcnelis@tuhs.temple.edu

First Name & Middle Initial & Last Name & Degree

Jennie Wong, RN, CCRP

Phone

215-707-0061

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

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

beilis@bcm.edu

First Name & Middle Initial & Last Name & Degree

Susana Lopez-Alamillo

Phone

713-798-2883

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

atf4c@hscmail.mcc.virginia.edu

First Name & Middle Initial & Last Name & Degree

Robin Kelly, RN

Phone

434-262-9820

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

shipe@surgery.wisc.edu

Phone

608-576-0788

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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