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New heart pump aims to make risky artery procedures safer

NCT ID NCT05334784

Disease control Sponsor: Abiomed 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 the Impella ECP, a temporary heart pump, in 856 adults undergoing high-risk angioplasty (a procedure to open blocked heart arteries). The pump is inserted before the procedure to help keep blood flowing. Researchers will track major heart and brain complications, bleeding, and device-related issues for 30 days after the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Impella ECP device
What this could lead to
If successful, this could provide a safer way to perform high-risk angioplasty in patients with complex heart disease.
What could go wrong
This is an early-stage study without a comparison group, so results may not prove the device is better than standard care. Risks include bleeding, vascular complications, and device-related injury.

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 856 people

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

Started

Dec 2022

Expected to finish

Dec 2026

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 90 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. Age ≥18 years and ≤90 years 2. Subject signed the informed consent 3. Subject is hemodynamically stable and a heart team, including a cardiac surgeon, has determined that an elective or urgent (not emergent) high-risk PCI is the appropriate therapeutic option Exclusion Criteria: 1. Aortic valve disease that is anticipated to be prohibitive to Impella ECP crossing, including greater than mild aortic stenosis 2. Previous aortic valve replacement or reconstruction 3. Thrombus in left ventricle 4. Subjects with known aortic vessel disease or with aortic dissection 5. Any contraindication that precludes placing an Impella including aortic, iliac or femoral disease such as tortuosity, extensive atherosclerotic disease or stenosis 6. Prior stroke with any permanent, significant (mRS\>2), neurologic deficit or any prior intracranial hemorrhage or any prior subdural hematoma or known intracranial pathology pre-disposing to intracranial bleeding, such as an arteriovenous malformation or mass 7. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure. Cardiogenic shock is defined as: systemic hypotension (systolic BP \<90 mmHg or the need for inotropes/pressors to maintain a systolic BP \>90 mmHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the catheterization laboratory, clinical evidence of end-organ hypoperfusion or use of IABP or any other circulatory support device 8. Infection of the proposed procedural access site or suspected systemic active infection, including any fever 9. Subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥8 weeks 10. Known contraindication to heparin (i.e., heparin-induced thrombocytopenia), contrast media or Study-required medication(s) (i.e., aspirin) 11. Platelet count \<75k, bleeding diathesis, coagulopathy or unwilling to receive blood transfusions 12. Subject is on dialysis 13. Suspected or known pregnancy 14. Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures 15. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary endpoint 16. Subject belongs to a vulnerable population \[Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention\] The above Inclusion/Exclusion criteria applies for Impella ECP Continued Access Protocol

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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

How to take part

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

  1. The places running it

    32 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

  • AdventHealth - Tampa

    Tampa, Florida, 33613, United States

  • Adventist Health Glendale

    Glendale, California, 91206, United States

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211, United States

  • Ascension St. John Hospital

    Detroit, Michigan, 48236, United States

  • Baylor Scott & White The Heart Hospital Plano

    Plano, Texas, 75093, United States

  • Buffalo General

    Buffalo, New York, 14203, United States

  • CUMC/ New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Hackensack University Medical Ctr

    Hackensack, New Jersey, 07601, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Keck Hospital of USC

    Los Angeles, California, 90033, United States

  • Lenox Hill Hospital

    New York, New York, 10075, United States

  • Loma Linda University Medical Center

    San Bernardino, California, 92354, United States

  • Manatee Memorial Hospital

    Bradenton, Florida, 34208, United States

  • Methodist Hospital - San Antonio

    San Antonio, Texas, 78229, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102, United States

  • North Florida Regional Medical Center

    Gainesville, Florida, 34208, United States

  • Ochsner Foundation Hospital

    New Orleans, Louisiana, 70121, United States

  • Oklahoma Heart Hospital - South

    Oklahoma City, Oklahoma, 73135, United States

  • Pima Heart & Vascular

    Tucson, Arizona, 85712, United States

  • Providence St. Patrick

    Missoula, Montana, 59802, United States

  • Providence St. Vincent Med Center

    Portland, Oregon, 97225, United States

  • Sentara Norfolk Health System

    Norfolk, Virginia, 23507, United States

  • Spectrum Health

    Grand Rapids, Michigan, 49503, United States

  • St. Cloud (CentraCare)

    Saint Cloud, Minnesota, 56303, United States

  • St. Joseph's Medical Center - Phoenix

    Phoenix, Arizona, 85013, United States

  • Texas Health Presbyterian Hospital Dallas

    Dallas, Texas, 75231, United States

  • The Valley Hospital

    Ridgewood, New Jersey, 07450, United States

  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

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