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

Sponsor

Evaheart, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT01187368

Collaborator

(none)

399

Enrollment

Locations

Arms

Anticipated Duration (Months)

28.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: EVAHEART Left Ventricular Assist System (LVAS) Device: HeartMate 3	N/A

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

Study Type:

Interventional

Anticipated 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.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 :

Mar 31, 2020

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

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 Names: 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 Names: HM3

Arm

Intervention/Treatment

Experimental: Evaheart LVAS (EVA2)

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 Names:

EVA2

Active Comparator: HeartMate 3 (HM3)

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 Names:

HM3

Outcome Measures

Primary Outcome Measures

Short-Term Primary Endpoint [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 [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

Change in KCCQ and EuroQol [Baseline versus POD 30, 90, 180, 360 and every 180 days]
Change in 6-minute walk test [Baseline versus POD 30, 90, 180, 360 and every 180 days]
NYHA functional class [Baseline versus POD 30, 90, 180, 360, and every 180 days]
Frequency and incidence of all re-operations [Discharge after implant through transplant or explant for recovery.]
Frequency and incidence of all rehospitalizations [Discharge after implant through transplant or explant for recovery.]
Incidence of adverse events, serious adverse events and UADEs [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 [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 [Up to 30 days post-transplant or post-explant]

Other Outcome Measures

Powered Secondary Endpoint: GI bleeding [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UF Health Shands Hospital	Gainesville	Florida	United States	32608
2	St. Vincent Hospital Indianapolis	Indianapolis	Indiana	United States	46260
3	University of Louisville	Louisville	Kentucky	United States	40202
4	Tufts Medical Center	Boston	Massachusetts	United States	02111
5	Atrium Health Sanger Heart and Vascular Institute	Charlotte	North Carolina	United States	28203
6	The Christ Hospital	Cincinnati	Ohio	United States	45219
7	Penn State Health Milton S Hershey Medical Center	Hershey	Pennsylvania	United States	17033
8	Temple University	Philadelphia	Pennsylvania	United States	19140
9	Baylor Scott and White, Dallas	Dallas	Texas	United States	75246
10	Baylor College of Medicine	Houston	Texas	United States	77030
11	Methodist Hospital - San Antonio	San Antonio	Texas	United States	78229
12	University of Virginia Medical Center	Charlottesville	Virginia	United States	22908
13	University of Washington Medical Center	Seattle	Washington	United States	98195
14	University of Wisconsin-Madison	Madison	Wisconsin	United States	53792