Clinical trial NCT05100836: SURPASS Impella 5.5 Study
Official title: SURPASS Study - The Surgical Unloading Renal Protection And Sustainable Support Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiogenic Shock
Acute Decompensated Heart Failure
Keywords: Impella
Impella 5.5
Bridge to next therapy
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-29
Enrollment: 1017
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Survival Outcome
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: MGH
state: Massachusetts
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: The Robert Wood Johnson University Hospital
state: New Jersey
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Health Baptist Medical Center
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Memorial Hermann Texas Medical Center
state: Texas
city: San Antonio
country: United States
facility: Methodist San Antonio Hospital
state: Texas
Study officials:
affiliation: Methodist San Antonio Hospital
name: Masaki Funamoto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hackensack Meridian Health
name: Mark Anderson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MGH
name: David D'Alessandro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampa General Hospital
name: Gundars Katlaps, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Robert Wood Johnson University Hospital
name: Anthony Lemaire, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Edward Soltesz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tufts Medical Center
name: Masashi Kawabori, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Advent Health Orlando
name: Ahmad Zeeshan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Fardad Esmailian, MD
role: PRINCIPAL_INVESTIGATOR
References: