SURPASS Impella 5.5 Study

Completed

• Conditions: Cardiogenic Shock; Acute Decompensated Heart Failure
• Interventions: Device: Impella 5.5

• Registration Number: NCT05100836
• Lead Sponsor: Abiomed Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-21
• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-10-29
• Status Verified: 2025-05
• Primary Completion: 2025-05-14
• Study Completion: 2025-05-14
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1017

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single arm all comers supported with Impella 5.5	Impella 5.5	-

Primary Outcome Measures

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

Trial Locations

Locations (15)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

MGH; 🇺🇸 Boston, Massachusetts, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Memorial Hermann Texas Medical Center; 🇺🇸 Houston, Texas, United States

Methodist San Antonio Hospital; 🇺🇸 San Antonio, Texas, United States

Northwestern University; 🇺🇸 Evanston, Illinois, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

The Robert Wood Johnson University Hospital; 🇺🇸 New Brunswick, New Jersey, United States

Advent Health Orlando; 🇺🇸 Orlando, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Integris Health Baptist Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States