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

E

Evaheart

Status

Suspended

Conditions

Heart Failure

Treatments

Device: HeartMate 3
Device: EVAHEART Left Ventricular Assist System (LVAS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01187368
020-1601-001-P01

Details and patient eligibility

About

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).

Full 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.

Enrollment

399 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

399 participants in 2 patient groups

Evaheart LVAS (EVA2)
Experimental group
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.
Treatment:
Device: EVAHEART Left Ventricular Assist System (LVAS)
HeartMate 3 (HM3)
Active Comparator group
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.
Treatment:
Device: HeartMate 3

Trial contacts and locations

12

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Central trial contact

Maricar Cruz; Lizatte Martinez

Data sourced from clinicaltrials.gov

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