Status:
SUSPENDED
Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System
Lead Sponsor:
Evaheart, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 Inclu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT01187368
Start Date
March 31 2020
End Date
July 31 2028
Last Update
May 14 2025
Active Locations (12)
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1
UF Health Shands Hospital
Gainesville, Florida, United States, 32608
2
Tampa General Hospital
Tampa, Florida, United States, 33606
3
St. Vincent Hospital Indianapolis
Indianapolis, Indiana, United States, 46260
4
University of Louisville
Louisville, Kentucky, United States, 40202