NCT05100836

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,017

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2025

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

4.6 years

First QC Date

October 12, 2021

Last Update Submit

May 15, 2025

Conditions

Cardiogenic ShockAcute Decompensated Heart Failure

Keywords

ImpellaImpella 5.5Bridge to next therapy

Outcome Measures

Primary Outcomes (1)

  • Survival Outcome

    The rate of patients who survived at Impella 5.5 explant, hospital discharge and follow-up up to 1 year

    One year

Study Arms (1)

Single arm all comers supported with Impella 5.5

Device: Impella 5.5

Interventions

Impella 5.5DEVICE

Impella 5.5 mechanical circulatory support

Single arm all comers supported with Impella 5.5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age ≥ 18 years
  • Subject has previously undergone an Impella 5.5 implant at a study site

You may not qualify if:

  • Patients not receiving Impella 5.5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Advent Health Orlando

Orlando, Florida, 302803, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MGH

Boston, Massachusetts, 02114, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

The Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Integris Health Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

Location

Methodist San Antonio Hospital

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Masaki Funamoto, MD

    Methodist San Antonio Hospital

    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

  • Ahmad Zeeshan, MD

    Advent Health Orlando

    PRINCIPAL INVESTIGATOR

  • Fardad Esmailian, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2021

First Posted

October 29, 2021

Study Start

September 21, 2020

Primary Completion

May 14, 2025

Study Completion

May 14, 2025

Last Updated

May 20, 2025

Record last verified: 2025-05

Locations

US(15)