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New heart pump trial aims to extend life for advanced heart failure patients

NCT ID NCT06526195

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a mechanical heart pump (HeartMate 3) can help people with advanced heart failure live longer and avoid serious complications like stroke or the need for a heart transplant. About 850 participants will either receive the pump or continue standard medical therapy. The goal is to see if the pump improves survival and quality of life over two years.

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 850 people

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

Started

Dec 2024

Expected to finish

Sep 2032

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: 1. Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure 2. LVEF ≤30% and Cardiac Index ≤ 2.5 L/min/m² 3. Limited functional status as demonstrated by 6MWT ≤ 350 m due to HF related reasons OR peak VO2 ≤ 14 mL/kg/min (or \<50% of predicted peak VO2 value) 4. NYHA Class IIIB or NYHA Class IV 5. Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months 6. Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant 7. Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group Randomization Criteria: 1. Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days. 2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days. 3. mean PAP ≥ 30 mmHg. 4. The subject will not be randomized if they have any other factor that represents inordinate risk for either continued GDMT or LVAD implant. Single Arm Registry Criteria: 1. Subject has received a CardioMEMS PA Sensor implant following enrollment in the trial. 2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days. 3. mean PAP \<30 mmHg Exclusion Criteria: 1. Subject is \< 18 years of age at the time of informed consent. 2. Dependent on IV inotrope in the last 30 days. 3. Contra-indications to HM3 LVAS or CardioMEMS HF system. 4. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy. 5. Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter. 6. Existence of ongoing MCS. 7. Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant. 8. History of any solid organ transplant. 9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management. 10. Presence of an active, uncontrolled infection. 11. Complex congenital heart disease. 12. Currently Pregnant or capable of becoming Pregnant and Unwilling to Use Contraception with LVAD. 13. History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (\>1 episode) pulmonary embolism and/or deep vein thrombosis. 14. Planned VAD or Bi-VAD support prior to enrollment. 15. Presence of any one of the following risk factors for or indications of severe end organ dysfunction or failure: 1. An INR ≥ 2.0 not due to anticoagulation therapy 2. An eGFR \< 30 mL/min/1.73 m2 and nonresponsive to diuretic therapy or receiving chronic dialysis. 3. Biopsy proven liver cirrhosis. 4. Need for chronic renal replacement therapy. 5. History of severe chronic obstructive pulmonary disease (COPD) defined by Forced Expiratory Volume FEV1 \< 30% predicted. 6. History of cerebrovascular disease with significant (\> 80%) uncorrected internal carotid stenosis. 7. Significant peripheral vascular disease (PVD) accompanied by ischemic rest pain or extremity ulceration. 16. Any condition other than HF that could limit survival to less than 24 months. 17. Participation in any other clinical investigation with an active treatment arm that is likely to confound study results or affect the study outcome.

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Conditions

The condition(s) this trial relates to.

advanced heart failure cardiovascular disorder heart disorder heart failure pulmonary hypertension

As listed by the trial registrant

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

Cardiovascular diseases Heart diseases Heart failure Pulmonary hypertension

How to take part

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

  1. The places running it

    68 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • A.O.U. Citta della Salute e della Scienza di Torino

    RECRUITING

    Turin, Piedmont, 10126, Italy

  • AKH -Wien

    RECRUITING

    Vienna, State of Vienna, 1090, Austria

  • Abington Memorial Hospital

    RECRUITING

    Abington, Pennsylvania, 19001, United States

  • Advocate Health & Hospitals Corporation

    RECRUITING

    Oakbrook Terrace, Illinois, 60181, United States

  • Allegheny General Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension Texas Cardiovascular

    RECRUITING

    Austin, Texas, 78705, United States

  • Aurora Medical Group

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Banner-University Medical Center Phoenix

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Baptist Health Medical Center

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Baylor University Hospital

    RECRUITING

    Dallas, Texas, 75246, United States

  • CHI St. Luke's Health Baylor College of Medicine Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Carolinas Medical Center

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Cleveland Clinic Florida

    RECRUITING

    Weston, Florida, 33331, United States

  • Deutsches Herzzentrum der Charité

    RECRUITING

    Berlin, State of Berlin, 13353, Germany

  • Erasmus MC - Thoraxcenter

    RECRUITING

    Rotterdam, Holland, 3015 CE, Netherlands

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Herzzentrum Leipzig GmbH

    RECRUITING

    Leipzig, Saxony, 04289, Germany

  • Houston Methodist

    RECRUITING

    Houston, Texas, 77030, United States

  • IKEM Prague

    RECRUITING

    Prague, CBohmia, 14021, Czechia

  • Integris Baptist Medical Center

    RECRUITING

    Oklahoma City, Oklahoma, 73112, United States

  • Kansas University Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • King Fahad Medical City

    RECRUITING

    Riyadh, Riyadh Region, 11525, Saudi Arabia

  • King Faisal Specialist Hospital

    RECRUITING

    Riyadh, Riyadh Region, 12713, Saudi Arabia

  • Maine Medical Center

    RECRUITING

    Portland, Maine, 04102, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, Saxon, 30625, Germany

  • Minneapolis Heart Institute

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Montefiore Medical Center - Moses Campus

    RECRUITING

    The Bronx, New York, 10467, United States

  • New Mexico Heart Institute

    RECRUITING

    Albuquerque, New Mexico, 87102, United States

  • New York-Presbyterian/Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Newark Beth Israel Medical Center

    RECRUITING

    Newark, New Jersey, 07112, United States

  • North Shore University Hospital

    RECRUITING

    Manhasset, New York, 11030, United States

  • Norton Hospital

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Oklahoma Heart Institute at Utica

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Penn State Milton S. Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Piedmont Augusta Hospital

    RECRUITING

    Augusta, Georgia, 30901, United States

  • Piedmont Heart Institute

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Prisma Health Midlands

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • Rigshospitalet

    RECRUITING

    Copenhagen, Copenhagen, 2100, Denmark

  • Saint Francis Hospital

    RECRUITING

    Tulsa, Oklahoma, 74136, United States

  • Scott & White Memorial Hospital

    RECRUITING

    Temple, Texas, 76508, United States

  • Shands at the University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

  • Spectrum Health Butterworth Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • St. Luke's Hospital

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • St. Vincent Hospital

    RECRUITING

    Indianapolis, Indiana, 46240, United States

  • Sutter Medical Center

    RECRUITING

    Sacramento, California, 95816, United States

  • The Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • The Heart Hospital Baylor Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • The Stern Cardiovascular Foundation

    RECRUITING

    Memphis, Tennessee, 38120, United States

  • UMC Utrecht

    RECRUITING

    Utrecht, Utrecht, 3584 CX, Netherlands

  • UTHealth Memorial Hermann

    RECRUITING

    Houston, Texas, 77030, United States

  • University of California at San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Iowa Hospitals & Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Utah Hospital

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • University of Virginia Medical Center

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Washington Hospital Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • WellStar Kennestone Hospital

    RECRUITING

    Marietta, Georgia, 30060, United States

More trials for these conditions

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