Cardiogenic ShockNCT05100836
SURPASS Impella 5.5 Study
An observational study of Cardiogenic Shock and Acute Decompensated Heart Failure, run by Abiomed Inc. at 15 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Acute Decompensated Heart Failure
- What is being tested?
- Impella 5.5
- Type of treatment
- Medical device
- How many people
- 1,017 participants
- Where
- 15 sitesUnited States
- Study dates
- 21 Sep 2020to 14 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years old and older who previously received an Impella 5.5 implant at the study site
Who may be able to join
- Age ≥ 18 years
- Subject has previously undergone an Impella 5.5 implant at a study site
Who cannot join
- Patients not receiving Impella 5.5
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Emory University Hospital
Atlanta, Georgia, 30322
Tufts Medical Center
Boston, Massachusetts, 02111
MGH
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44195
Northwestern University
Evanston, Illinois, 60208
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Memorial Hermann Texas Medical Center
Houston, Texas, 77030
Cedars Sinai Medical Center
Los Angeles, California, 90048
The Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Integris Health Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Advent Health Orlando
Orlando, Florida, 302803
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
Methodist San Antonio Hospital
San Antonio, Texas, 78229
Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: 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.
- Being tested
- Impella 5.5
- Keywords
- Impella, Impella 5.5, Bridge to next therapy
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impella 5.5Device
Impella 5.5 mechanical circulatory support
| Study group | Role | What they receive |
|---|---|---|
| Single arm all comers supported with Impella 5.5 | Not described Receives: Device: Impella 5.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Outcome
The rate of patients who survived at Impella 5.5 explant, hospital discharge and follow-up up to 1 year
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start21 Sep 2020
- Primary completion14 May 2025
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masaki Funamoto, MD, Principal investigator, Methodist San Antonio HospitalMark Anderson, MD, Principal investigator, Hackensack Meridian HealthDavid D'Alessandro, MD, Principal investigator, MGHGundars Katlaps, MD, Principal investigator, Tampa General HospitalAnthony Lemaire, MD, Principal investigator, Robert Wood Johnson University HospitalEdward Soltesz, MD, Principal investigator, The Cleveland ClinicMasashi Kawabori, MD, Principal investigator, Tufts Medical CenterAhmad Zeeshan, MD, Principal investigator, Advent Health Orlando
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100836
- Sponsor's protocol ID
- Surpass
- Status last verified
- May 2025
- First submitted
- 12 Oct 2021
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SURPASS Study - The Surgical Unloading Renal Protection And Sustainable Support Study
- ClinicalTrials.gov ID
- NCT05100836
- Acronym / sponsor ID
- Surpass
- Keywords
- Impella, Impella 5.5, Bridge to next therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,017 participants (actual)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm all comers supported with Impella 5.5 | – | Device: Impella 5.5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years old and older who previously received an Impella 5.5 implant at the study site
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Subject has previously undergone an Impella 5.5 implant at a study site
Key exclusion criteria (1 listed)
- Patients not receiving Impella 5.5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impella 5.5Impella 5.5 mechanical circulatory support | Device | Single arm all comers supported with Impella 5.5 |
Primary outcome
Survival Outcome
Time frame: One year
The rate of patients who survived at Impella 5.5 explant, hospital discharge and follow-up up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masaki Funamoto, MD principal investigator
Methodist San Antonio Hospital
Mark Anderson, MD principal investigator
Hackensack Meridian Health
David D'Alessandro, MD principal investigator
MGH
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Acute Decompensated Heart Failure, run by Abiomed Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Outcome (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.