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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
399
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.
UF Health Shands Hospital
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
St. Vincent Hospital Indianapolis
Indianapolis, Indiana, United States
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
Time frame: 6 months
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
Time frame: 24 months
Change in KCCQ and EuroQol
Time frame: Baseline versus POD 30, 90, 180, 360 and every 180 days
Change in 6-minute walk test
Time frame: Baseline versus POD 30, 90, 180, 360 and every 180 days
NYHA functional class
Time frame: Baseline versus POD 30, 90, 180, 360, and every 180 days
Frequency and incidence of all re-operations
Time frame: Discharge after implant through transplant or explant for recovery.
Frequency and incidence of all rehospitalizations
Time frame: Discharge after implant through transplant or explant for recovery.
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).
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University of Louisville
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
The Christ Hospital
Cincinnati, Ohio, United States
Penn State Health Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Baylor Scott and White, Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Methodist Hospital - San Antonio
San Antonio, Texas, United States
...and 2 more locations
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)
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)
Post-transplant or post-explant survival
Time frame: Up to 30 days post-transplant or post-explant