SURPASS Study - The Surgical Unloading Renal Protection And Sustainable Support Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abiomed Inc.
- Enrollment
- 1,017
- Locations
- 15
- Primary Endpoint
- Survival Outcome
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Survival Outcome
Time Frame: One year
The rate of patients who survived at Impella 5.5 explant, hospital discharge and follow-up up to 1 year
Secondary Outcomes
No secondary outcomes reported