SURPASS Impella 5.5 Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05100836

Enrollment

1017

Registered

2021-10-29

Start date

2020-09-21

Completion date

2025-05-14

Last updated

2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Decompensated Heart Failure, Cardiogenic Shock

Keywords

Impella, Impella 5.5, Bridge to next therapy

Brief 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.

Interventions

DEVICEImpella 5.5

Impella 5.5 mechanical circulatory support

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Survival Outcome	One year	The rate of patients who survived at Impella 5.5 explant, hospital discharge and follow-up up to 1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026