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

Not Applicable

Suspended

• Conditions: Heart Failure
• Interventions: Device: HeartMate 3; Device: EVAHEART Left Ventricular Assist System (LVAS)

• Registration Number: NCT01187368
• Lead Sponsor: Evaheart, Inc.

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.

Study Timeline

• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-24
• Study Start: 2020-03-31
• Status Verified: 2024-09
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2027-07-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 399

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
HeartMate 3 (HM3)	HeartMate 3	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.
Evaheart LVAS (EVA2)	EVAHEART Left Ventricular Assist System (LVAS)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
Change in KCCQ and EuroQol	Baseline versus POD 30, 90, 180, 360 and every 180 days
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

Trial Locations

Locations (12)

UF Health Shands Hospital; 🇺🇸 Gainesville, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

St. Vincent Hospital Indianapolis; 🇺🇸 Indianapolis, Indiana, United States

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

University of Virginia Medical Center; 🇺🇸 Charlottesville, Virginia, United States

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States