Clinical trial NCT01187368: Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System
Official title: Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System: the COMPETENCE Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
LVAS
LVAD
Bridge-to-transplant
Continuous flow pump
Destination therapy
Lead sponsor: Evaheart, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-24
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: Short-Term Primary Endpoint
timeFrame: 6 months
measure: Long-Term Primary Endpoint
timeFrame: 24 months
Secondary outcomes:
measure: Change in KCCQ and EuroQol
timeFrame: Baseline versus POD 30, 90, 180, 360 and every 180 days
measure: Change in 6-minute walk test
timeFrame: Baseline versus POD 30, 90, 180, 360 and every 180 days
measure: NYHA functional class
timeFrame: Baseline versus POD 30, 90, 180, 360, and every 180 days
measure: Frequency and incidence of all re-operations
timeFrame: Discharge after implant through transplant or explant for recovery.
measure: Frequency and incidence of all rehospitalizations
timeFrame: Discharge after implant through transplant or explant for recovery.
measure: Incidence of adverse events, serious adverse events and UADEs
timeFrame: 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)
measure: Incidence of all device failures and device malfunctions
timeFrame: 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)
measure: Post-transplant or post-explant survival
timeFrame: Up to 30 days post-transplant or post-explant
Other outcomes:
measure: Powered Secondary Endpoint: GI bleeding
timeFrame: 24 months
Locations:
city: Gainesville
country: United States
facility: UF Health Shands Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Indianapolis
country: United States
facility: St. Vincent Hospital Indianapolis
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Hershey
country: United States
facility: Penn State Health Milton S Hershey Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Scott and White, Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital - San Antonio
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: Evaheart, Inc.
name: Tadashi Motomura, MD, PhD
role: STUDY_DIRECTOR
References: