NCT01187368

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).

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
399

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
27mo left

Started Mar 2020

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

12 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Mar 2020Jul 2028

First Submitted

Initial submission to the registry

August 19, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
9.6 years until next milestone

Study Start

First participant enrolled

March 31, 2020

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

7.3 years

First QC Date

August 19, 2010

Last Update Submit

March 24, 2026

Conditions

Heart Failure

Keywords

Heart failureLVASLVADBridge-to-transplantContinuous flow pumpDestination therapy

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    24 months

Secondary Outcomes (8)

  • 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.

  • +3 more secondary outcomes

Other Outcomes (1)

  • Powered Secondary Endpoint: GI bleeding

    24 months

Study Arms (2)

Evaheart LVAS (EVA2)

EXPERIMENTAL

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.

Device: EVAHEART Left Ventricular Assist System (LVAS)

HeartMate 3 (HM3)

ACTIVE COMPARATOR

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.

Device: HeartMate 3

Interventions

EVAHEART Left Ventricular Assist System (LVAS)DEVICE

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.

Also known as: EVA2
Evaheart LVAS (EVA2)
HeartMate 3DEVICE

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.

Also known as: HM3
HeartMate 3 (HM3)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Planned Bi-VAD support prior to enrollment
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

UF Health Shands Hospital

Gainesville, Florida, 32608, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

St. Vincent Hospital Indianapolis

Indianapolis, Indiana, 46260, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Penn State Health Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Baylor Scott and White, Dallas

Dallas, Texas, 75246, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Methodist Hospital - San Antonio

San Antonio, Texas, 78229, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Tadashi Motomura, MD, PhD

    Evaheart, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2010

First Posted

August 24, 2010

Study Start

March 31, 2020

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2028

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

US(12)