SURPASS Impella 5.5 Study

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

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 Overview

• Status: Active, not recruiting
• Conditions: Acute Decompensated Heart Failure; Cardiogenic Shock
• Intervention / Treatment: Device: Impella 5.5

• Study Type: Observational
• Enrollment (Actual): 1017

Contacts and Locations

• Study Contact: Name: Amin Medjamia, MD; Phone Number: 978-646-1740; Email: amedjamia@abiomed.com
• Study Contact Backup: Name: Oksana Bradley, MD; Phone Number: 978-317-7982; Email: obradley@abiomed.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
  • Florida
    • Orlando, Florida, United States, 302803
      • Advent Health Orlando
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern University
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 02114
      • MGH
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • New Brunswick, New Jersey, United States, 08901
      • The Robert Wood Johnson University Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Health Baptist Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann Texas Medical Center
    • San Antonio, Texas, United States, 78229
      • Methodist San Antonio Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years old and older who previously received an Impella 5.5 implant at the study site

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single arm all comers supported with Impella 5.5	Device: Impella 5.5; Impella 5.5 mechanical circulatory support

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abiomed Inc.
• Investigators: Principal Investigator: Mark Anderson, MD, Hackensack Meridian Health; Principal Investigator: David D'Alessandro, MD, MGH; Principal Investigator: Gundars Katlaps, MD, Tampa General Hospital; Principal Investigator: Anthony Lemaire, MD, Robert Wood Johnson University Hospital; Principal Investigator: Edward Soltesz, MD, The Cleveland Clinic; Principal Investigator: Masashi Kawabori, MD, Tufts Medical Center; Principal Investigator: Fardad Esmailian, MD, Cedars-Sinai Medical Center; Principal Investigator: Masaki Funamoto, MD, Methodist San Antonio Hospital; Principal Investigator: Ahmad Zeeshan, MD, Advent Health Orlando

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Estimated): December 21, 2024
• Study Completion (Estimated): December 21, 2024

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Impella; Impella 5.5; Bridge to next therapy
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Shock; Myocardial Infarction; Infarction; Shock, Cardiogenic
• Other Study ID Numbers: Surpass

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes