SURPASS Impella 5.5 Study

Abiomed

Status: Completed

Conditions: Acute Decompensated Heart Failure; Cardiogenic Shock

Treatments: Device: Impella 5.5

Study type: Observational

Funder types: Industry

Identifiers

NCT05100836

Surpass

Details and patient eligibility

About

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.

Enrollment: 1,017 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

1,017 participants in 1 patient group

Single arm all comers supported with Impella 5.5

Treatment:

Device: Impella 5.5