SURPASS Impella 5.5 Study

Last updated: January 28, 2025
Sponsor: Abiomed Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Heart Failure

Circulation Disorders

Treatment

Impella 5.5

Clinical Study ID

NCT05100836
Surpass
  • Ages > 18
  • All Genders

Study Summary

A multi-center, prospective & retrospective, observational single-arm study of the clinical outcomes up to one year collected from electronic health records of patients which have undergone standard of care implantation of Impella 5.5, regardless of clinical situation or indication. All patients will be enrolled via an IRB-approved Waiver of Informed Consent and HIPAA Authorization.

All patients who were supported retrospectively (prior to site IRB approval) with Impella 5.5 at the investigative site will be entered into the SURPASS registry and specified as the retrospective cohort.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Subject has previously undergone an Impella 5.5 implant at a study site

Exclusion

Exclusion Criteria:

  • Patients not receiving Impella 5.5

Study Design

Total Participants: 1017
Treatment Group(s): 1
Primary Treatment: Impella 5.5
Phase:
Study Start date:
September 21, 2020
Estimated Completion Date:
March 01, 2025

Connect with a study center

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Advent Health Orlando

    Orlando, Florida 302803
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Northwestern University

    Evanston, Illinois 60208
    United States

    Site Not Available

  • MGH

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • The Robert Wood Johnson University Hospital

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Integris Health Baptist Medical Center

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15219
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Memorial Hermann Texas Medical Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Methodist San Antonio Hospital

    San Antonio, Texas 78229
    United States

    Site Not Available

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