SURPASS Impella 5.5 Study

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.

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Key information

Conditions

Cardiogenic Shock Acute Decompensated Heart Failure Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars Sinai Medical Center, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 years
Subject has previously undergone an Impella 5.5 implant at a study site

Exclusion criteria

Patients not receiving Impella 5.5

Treatment and study plan

Impella 5.5

Device

Impella 5.5 mechanical circulatory support

Primary outcomes

Survival Outcome

Time frame: One year

The rate of patients who survived at Impella 5.5 explant, hospital discharge and follow-up up to 1 year

Sponsors and collaborators

Lead sponsor

Abiomed Inc.

Industry

Registry information

Official study title

SURPASS Study - The Surgical Unloading Renal Protection And Sustainable Support Study

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2025
First posted: Oct 29, 2021
Registry last updated: May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting