SURPASS Impella 5.5 Study

NCT ID: NCT05100836

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1017 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-21

Study Completion Date

2025-05-14

Brief Summary

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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

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Conditions

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Cardiogenic Shock Acute Decompensated Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single arm all comers supported with Impella 5.5

Impella 5.5

Intervention Type DEVICE

Impella 5.5 mechanical circulatory support

Interventions

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Impella 5.5

Impella 5.5 mechanical circulatory support

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abiomed Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Masaki Funamoto, MD

Role: PRINCIPAL_INVESTIGATOR

Methodist San Antonio Hospital

Mark Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

David D'Alessandro, MD

Role: PRINCIPAL_INVESTIGATOR

MGH

Gundars Katlaps, MD

Role: PRINCIPAL_INVESTIGATOR

Tampa General Hospital

Anthony Lemaire, MD

Role: PRINCIPAL_INVESTIGATOR

Robert Wood Johnson University Hospital

Edward Soltesz, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Masashi Kawabori, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Ahmad Zeeshan, MD

Role: PRINCIPAL_INVESTIGATOR

Advent Health Orlando

Fardad Esmailian, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

Advent Health Orlando

Orlando, Florida, United States

Site Status

Tampa General Hospital

Tampa, Florida, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Northwestern University

Evanston, Illinois, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

MGH

Boston, Massachusetts, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

The Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Integris Health Baptist Medical Center

Oklahoma City, Oklahoma, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Memorial Hermann Texas Medical Center

Houston, Texas, United States

Site Status

Methodist San Antonio Hospital

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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Surpass

Identifier Type: -

Identifier Source: org_study_id

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