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

NCT01187368 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2026-03-27

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

EVAHEART 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.

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.

Sponsors & Collaborators

  • Evaheart, Inc.

    lead INDUSTRY

Principal Investigators

  • Tadashi Motomura, MD, PhD · Evaheart, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2027-07-31
Completion
2028-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01187368 on ClinicalTrials.gov