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SURPASS Impella 5.5 Study

NCT05100836 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1017

Last updated 2025-05-20

No results posted yet for this 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.

Conditions

  • Cardiogenic Shock
  • Acute Decompensated Heart Failure

Interventions

DEVICE

Impella 5.5

Impella 5.5 mechanical circulatory support

Sponsors & Collaborators

  • Abiomed Inc.

    lead INDUSTRY

Principal Investigators

  • Masaki Funamoto, MD · Methodist San Antonio Hospital

  • Mark Anderson, MD · Hackensack Meridian Health

  • David D'Alessandro, MD · MGH

  • Gundars Katlaps, MD · Tampa General Hospital

  • Anthony Lemaire, MD · Robert Wood Johnson University Hospital

  • Edward Soltesz, MD · The Cleveland Clinic

  • Masashi Kawabori, MD · Tufts Medical Center

  • Ahmad Zeeshan, MD · Advent Health Orlando

  • Fardad Esmailian, MD · Cedars-Sinai Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2025-05-14
Completion
2025-05-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05100836 on ClinicalTrials.gov