NCT05100836

SURPASS Impella 5.5 Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,017 (actual)
• Sponsor: Abiomed Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Impella 5.5	Impella 5.5 mechanical circulatory support

Timeline

• Start date: 2020-09-21
• Primary completion: 2025-05-14
• Completion: 2025-05-14
• First posted: 2021-10-29
• Last updated: 2025-05-20

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study