SURPASS Impella 5.5 Study

Completed

Conditions studied: Cardiogenic Shock, Acute Decompensated Heart Failure

In brief

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.

Key facts

Study ID

NCT05100836

Run by

Abiomed Inc.

People needed

1017

Starts

2020-09-21

Expected to finish

2025-05-14

Last updated by the study team

2025-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Patients not receiving Impella 5.5

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States
• Advent Health Orlando — Orlando, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northwestern University — Evanston, Illinois, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• MGH — Boston, Massachusetts, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• The Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Integris Health Baptist Medical Center — Oklahoma City, Oklahoma, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Memorial Hermann Texas Medical Center — Houston, Texas, United States
• Methodist San Antonio Hospital — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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