Cardiogenic ShockNCT06308055
Abiomed Impella RT-DAQ - Observational Study
An observational study of Cardiogenic Shock, run by Abiomed Inc. at 4 sites in 3 countries.
Trial summary
Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Data Acquisition
- How many people
- 125 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 4 Oct 2024to 31 Dec 2027
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 requiring cardiac Impella pump-support and intensive care therapy including cardiac output monitoring, eg. by pulmonary artery catheter at some point of therapy. Initially, a collection of 250 patient days is aimed for. It is expected that each patient will be monitored by PAC for at least 48 hours, thus approximately 125 patients will be needed to achieve study objectives.
Who may be able to join
- Ongoing or planned intensive care management with Impella support
- Presence or planned placement of a cardiac output measurement
- Preferentially pulmonary catheter (including cardiac output (CO) preferred as continuous measurement)
- Other means of discontinuous CO measurement incl. echocardiography, other thermodilution methods
Who cannot join
- Age < 18 years
- Pregnancy
- Anticipated support duration <24 h
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Germany2 sites, 1 recruiting
- Active, not recruiting
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
- Not yet recruiting
UKSH Campus Kiel
Kiel, Schleswig-Holstein, 24105
Bernd Panholzer, MD
Italy1 site, 1 recruiting
- Not yet recruiting
IRCCS Ospedale San Raffaele
Milan, MI, 20132
Alberto Zangrillo, MD
Luca Baldetti, MD
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsspital Basel
Basel
Patrick Hunziker, MD
Patrick Hunziker, MD
About this study
Official title: Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition
Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition
Read the detailed description
The objective of this study is to develop algorithms for determining the cardiac output through the synchronous acquisition of hemodynamic data from the pulmonary artery catheter or other pressure sensors and Impella using a network module, which can replace invasive hemodynamic monitoring in the future.
- Conditions
- Cardiogenic Shock
- Being tested
- Data Acquisition
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data AcquisitionOther
Develop algorithms for determining the cardiac output through the synchronous acquisition of hemodynamic data from the pulmonary artery catheter or other pressure sensors and Impella using a network module.
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of hemodynamic parameters (Cardiac Output in l/min)
Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access.
Measured: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
Collection of hemodynamic parameters (Blood Pressure in mmHg, Pulmonary Artery Pressure in mmHg, Central Venous Pressure in mmHg, Pulmonary Capillary Wedge Pressure in mmHg)
Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access.
Measured: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
Collection of hemodynamic parameters (Mixed Venous Saturation in %)
Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access.
Measured: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
Collection of hemodynamic parameters (Pulmonary Vascular Resistance in In dynes/sec/cm-5 )
Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access.
Measured: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
Secondary outcomes (1)
Rate of Patient Survival
Measured: Once the Impella support is permanently weaned, on average 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start4 Oct 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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
- 125 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Kersten, MD, Principal investigator, Uniklinik RWTH Aachen, Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308055
- Sponsor's protocol ID
- 2022-R01
- Status last verified
- Jun 2026
- First submitted
- 1 Feb 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition
- ClinicalTrials.gov ID
- NCT06308055
- Acronym / sponsor ID
- 2022-R01
- Conditions
- Cardiogenic Shock
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Mar 2024 (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.
Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition
Detailed description
The objective of this study is to develop algorithms for determining the cardiac output through the synchronous acquisition of hemodynamic data from the pulmonary artery catheter or other pressure sensors and Impella using a network module, which can replace invasive hemodynamic monitoring in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring cardiac Impella pump-support and intensive care therapy including cardiac output monitoring, eg. by pulmonary artery catheter at some point of therapy. Initially, a collection of 250 patient days is aimed for. It is expected that each patient will be monitored by PAC for at least 48 hours, thus approximately 125 patients will be needed to achieve study objectives.
Key inclusion criteria (4 listed)
- Ongoing or planned intensive care management with Impella support
- Presence or planned placement of a cardiac output measurement
Key exclusion criteria (3 listed)
- Age < 18 years
- Pregnancy
- Anticipated support duration <24 h
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 |
|---|---|---|
| Data AcquisitionDevelop algorithms for determining the cardiac output through the synchronous acquisition of hemodynamic data from the pulmonary artery catheter or other pressure sensors and Impella using a network module. | Other | – |
Primary outcome
Collection of hemodynamic parameters (Cardiac Output in l/min)
Time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access.
Collection of hemodynamic parameters (Blood Pressure in mmHg, Pulmonary Artery Pressure in mmHg, Central Venous Pressure in mmHg, Pulmonary Capillary Wedge Pressure in mmHg)
Time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access.
Collection of hemodynamic parameters (Mixed Venous Saturation in %)
Time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access.
Collection of hemodynamic parameters (Pulmonary Vascular Resistance in In dynes/sec/cm-5 )
Time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access.
1 secondary outcome
Rate of Patient Survival
Time frame: Once the Impella support is permanently weaned, on average 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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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.
Alexander Kersten, MD principal investigator
Uniklinik RWTH Aachen, Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock, run by Abiomed Inc. at 4 sites in 3 countries.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Italy, Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Goetzenich, MD, PhD, MBA, FAHA, FESC (+49 241 8860 ext. 0, AGoetze1@ITS.JNJ.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of hemodynamic parameters (Cardiac Output in l/min) (time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days). The study lists 4 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 17 Jun 2026.