Cardiogenic ShockNCT05820451
Impella Real-World Surveillance of Patients Using Sodium Bicarbonate
An observational study of Cardiogenic Shock and High Risk PCI, run by Abiomed Inc. at 20 sites in United States.
Trial summary
The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiogenic Shock, High Risk PCI
- What is being tested?
- Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution and Impella RP with Sodium Bicarbonate used as purge solution
- Type of treatment
- Medical device
- How many people
- 312 participants
- Where
- 20 sitesUnited States
- Study dates
- 15 Dec 2022to 22 Feb 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All subjects who received an Impella in which a bicarbonate-based purge solution was used
Who may be able to join
- Left-sided Impella with bicarbonate in the purge
- Right-sided Impella with bicarbonate in the purge
Who cannot join
- Known LV thrombus
- Right Sided Impella
- Known pulmonary thromboemboli
- Known DVT
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of Alabama
Birmingham, Alabama, 35233
Christ Hospital
Cincinnatti, Ohio, 45219
Baylor Scott and White (Baylor Heart and Vascular)
Dallas, Texas, 75226
Henry Ford
Detroit, Michigan, 48202
Ascension St. John Hospital
Detroit, Michigan, 48236
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Keck USC Medical Center
Los Angeles, California, 90033
Providence St. Patrick
Missoula, Montana, 59802
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
University of Nebraska
Omaha, Nebraska, 68105
Advent Helath Orlando
Orlando, Florida, 32804
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Montefiore Medical Center - Moses
Portland, Oregon, 97205
Legacy Emanuel
Portland, Oregon, 97227
Oregon Health & Science University
Portland, Oregon, 97239
Providence Sacred Heart
Spokane, Washington, 99204
MultiCare Tacoma General
Tacoma, Washington, 98405
Tampa General Hospital
Tampa, Florida, 33606
Pima Heart and Vascular (Tuscon Medical Center)
Tucson, Arizona, 85712
About this study
The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.
- Conditions
- Cardiogenic Shock, High Risk PCI
- Being tested
- Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution, Impella RP with Sodium Bicarbonate used as purge solution
- 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 CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solutionDevice
US commercially approved Abiomed left sided hemodynamic support devices (Impella) will be included.
Impella RP with Sodium Bicarbonate used as purge solutionDevice
US commercially approved Abiomed right sided hemodynamic support devices (Impella) will be included.
| Study group | Role | What they receive |
|---|---|---|
| Left sided device | All patients implanted with a left sided support Impella device - this includes but is not limited to Impella 2.5, Impella CP, Impella 5.0, Impella 5.5. Receives: Device: Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution | |
| Right sided device | All patients implanted with a right sided support Impella device -this includes the Impella RP Receives: Device: Impella RP with Sodium Bicarbonate used as purge solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint Left Sided Impella
Rate of heiarchical composite of stroke, transient ischemic attack (TIA), left ventricular (LV) thrombus
Measured: From hospital admission until hospital discharge, average 5 days
Primary Endpoint Right Sided Impella
Rate of heiarchical composite of pulmonary thromboemboli and deep vein thrombosis (DVT)
Measured: From hospital admission until hospital discharge, average 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start15 Dec 2022
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
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.
- More trials run by Abiomed Inc.The sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amin Medjamia, MD, Study director, Abiomed Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820451
- Sponsor's protocol ID
- ABMD-CIP-21-02-SS01
- Status last verified
- Aug 2024
- First submitted
- 24 Mar 2023
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impella Real-World Surveillance of Patients Using Sodium Bicarbonate
- ClinicalTrials.gov ID
- NCT05820451
- Acronym / sponsor ID
- ABMD-CIP-21-02-SS01
- Conditions
- Cardiogenic Shock, High Risk PCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 19 Apr 2023 (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.
The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left sided device | – | Device: Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solutionAll patients implanted with a left sided support Impella device - this includes but is not limited to Impella 2.5, Impella CP, Impella 5.0, Impella 5.5. |
| Right sided device | – | Device: Impella RP with Sodium Bicarbonate used as purge solutionAll patients implanted with a right sided support Impella device -this includes the Impella RP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All subjects who received an Impella in which a bicarbonate-based purge solution was used
Key inclusion criteria (2 listed)
- Left-sided Impella with bicarbonate in the purge
- Right-sided Impella with bicarbonate in the purge
Key exclusion criteria (4 listed)
- Known LV thrombus
- Right Sided Impella
- Known pulmonary thromboemboli
- Known DVT
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 CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solutionUS commercially approved Abiomed left sided hemodynamic support devices (Impella) will be included. | Device | Left sided device |
| Impella RP with Sodium Bicarbonate used as purge solutionUS commercially approved Abiomed right sided hemodynamic support devices (Impella) will be included. | Device | Right sided device |
Primary outcome
Primary Endpoint Left Sided Impella
Time frame: From hospital admission until hospital discharge, average 5 days
Rate of heiarchical composite of stroke, transient ischemic attack (TIA), left ventricular (LV) thrombus
Primary Endpoint Right Sided Impella
Time frame: From hospital admission until hospital discharge, average 5 days
Rate of heiarchical composite of pulmonary thromboemboli and deep vein thrombosis (DVT)
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 4 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Amin Medjamia, MD study director
Abiomed Inc.
20 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 High Risk PCI, run by Abiomed Inc. at 20 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 4 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 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
Primary Endpoint Left Sided Impella (time frame: From hospital admission until hospital discharge, average 5 days). The study lists 2 primary outcomes in all. 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 4 Sep 2024.