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New heart pump device tested in High-Risk angioplasty patients

NCT ID NCT07001332

Disease control Sponsor: Magenta Medical Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 2 times

Summary

This study tests a new device called the Elevate™ heart pump in 290 people who need high-risk angioplasty (a procedure to open blocked heart arteries). The pump helps keep blood flowing during the procedure. The goal is to see if it is safer and works better than current methods. Participants are randomly assigned to get the new pump or standard care.

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 290 people

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

Started

Jul 2025

Expected to finish

Sep 2027

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 to 88 years

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. Non-emergent, percutaneous coronary intervention is planned on at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis). 2. A heart team that includes an interventional cardiologist and cardiac surgeon has determined that HR- PCI is an appropriate therapeutic option. 3. Participant signed the informed consent. Exclusion Criteria: 1. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure. 2. Prior stroke with any permanent, significant (mRS\>2) neurological deficit, or stroke or TIA within 3 months prior to enrollment. 3. Any condition or scheduled surgery that will require discontinuation of the antiplatelet and/or anticoagulation therapy within 90 days of the index procedure. 4. Evidence of left ventricular thrombus. 5. Aortic valve stenosis/calcification (valve area ≤ 1.5 cm2). 6. ≥ Moderate aortic valve regurgitation (≥ 2+ on a 4-grade scale by transthoracic echocardiography). 7. Femoral access site incompatibility that precludes placement of either the Treatment or Control device. 8. Patient on dialysis. 9. Known or suspected coagulopathy OR abnormal coagulation parameters. 10. Known allergy, sensitivity or intolerance to nickel. 11. Infection of the proposed procedural access site; OR suspected systemic active infection, including any fever or known active COVID-19 infection. 12. Allergy, sensitivity or intolerance to heparin, or contrast media, including known heparin-induced thrombocytopenia (HIT). 13. Any non-cardiac condition with a life expectancy \< 12 months. 14. Subject participation in another investigational drug or device trial (with the exception of post-market registries and observational studies, subject to Sponsor review and approval). 15. Pregnancy or breast-feeding. 16. Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromise the participant's ability to provide written informed consent and/or to comply with study procedures. 17. Subject belongs to a vulnerable population.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

High-risk percutaneous coronary intervention (high-risk pci)

How to take part

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

  1. The places running it

    33 sites. 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

  • Advocate Aurora Health Research Institute- St. Luke's Medical Center

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Atlantic Health System

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Banner-University Medical Center

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Brigham & Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Buffalo General Medical Center

    RECRUITING

    Buffalo, New York, 14203, United States

  • Columbia University Medical Center/NYPH

    RECRUITING

    New York, New York, 10032, United States

  • Emory University Hospital / Emory University Hospital Midtown/ Emory Saint Joseph's Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • HonorHealth Scottsdale Shea Medical Center/HonorHealth Deer Valley Medical Center

    RECRUITING

    Scottsdale, Arizona, 85260, United States

  • Inova Schar Heart & Vascular

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Kaiser Permanente

    RECRUITING

    Clackamas, Oregon, 97015, United States

  • Maimonides Health

    RECRUITING

    Brooklyn, New York, 11219, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mercy Health

    RECRUITING

    Cincinnati, Ohio, 45211, United States

  • Minneapolis Heart Institute

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • NYU Langone/Bellevue/Long Island

    RECRUITING

    New York, New York, 10023, United States

  • Northwell Health

    RECRUITING

    Manhasset, New York, 11030, United States

  • Robert Wood Johnson University Hospital

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • St. Elizabeth Healthcare

    RECRUITING

    Edgewood, Kentucky, 41017, United States

  • St. Luke's Hospital of Kansas City

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Swedish Cherry Hill

    RECRUITING

    Seattle, Washington, 98122, United States

  • Tampa General/USF

    RECRUITING

    Tampa, Florida, 33606, United States

  • TriStar Centennial Medical Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • UC San Diego Medical Center

    RECRUITING

    La Jolla, California, 92093, United States

  • UMass Memorial Medical Center

    RECRUITING

    Worcester, Massachusetts, 01605, United States

  • University of California at San Francisco Medical Center/Zuckerberg San Francisco General

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Illinois at Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Weill Cornell Medical Center

    RECRUITING

    New York, New York, 10065, United States

  • Wellstar Health System

    RECRUITING

    Marietta, Georgia, 30062, United States

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