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NCT05100836 Clinical Trial

SURPASS Impella 5.5 Study

Cardiogenic Shock Clinical Trial

Official title:
SURPASS Study - The Surgical Unloading Renal Protection And Sustainable Support Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05100836
Other study ID # Surpass
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 21, 2020
Est. completion date December 21, 2024

Study information
Verified date June 2024
Source Abiomed Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1017
Est. completion date December 21, 2024
Est. primary completion date December 21, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Impella 5.5
Impella 5.5 mechanical circulatory support

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

Sponsors (1)
Lead Sponsor Collaborator
Abiomed Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival Outcome The rate of patients who survived at Impella 5.5 explant, hospital discharge and follow-up up to 1 year One year
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