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New heart pump aims to keep patients alive without major complications

NCT ID NCT01187368

Disease control Sponsor: Evaheart, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a new heart pump (EVAHEART®2) to a current pump in 399 adults with severe heart failure. The goal is to see if the new pump helps people survive until a heart transplant or recover enough to have the pump removed, without suffering a disabling stroke or severe right heart failure. Participants will be followed for up to 24 months after implantation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 399 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2020

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

advanced heart failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Baylor Scott and White, Dallas

    Dallas, Texas, 75246, United States

  • Methodist Hospital - San Antonio

    San Antonio, Texas, 78229, United States

  • Penn State Health Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • St. Vincent Hospital Indianapolis

    Indianapolis, Indiana, 46260, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UF Health Shands Hospital

    Gainesville, Florida, 32608, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908, United States

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53792, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.