Heart Failure
Conditions
Keywords
Heart failure, LVAS, LVAD, Bridge-to-transplant, Continuous flow pump, Destination therapy
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.
Interventions
DEVICEEVAHEART 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.
DEVICEHeartMate 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.
Sponsors
Evaheart, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Contacts
STUDY_DIRECTORTadashi Motomura, MD, PhD
Evaheart, Inc.
Outcome results
None listed