Cardiogenic ShockPulseSENCT05106491
Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients
A study testing Synchronized Cardiac Support with the icor kit in people with Cardiogenic Shock and Extracorporeal Membrane Oxygenation, run by Xenios AG at 2 sites in Germany.
Trial summary
The study aims to investigate the safety and efficacy of the Synchronized Cardiac Support treatment wit the icor kit and the Xenios console with modified sensor box ECG and Software Version 3.2.4 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation, ECLS
- What is being tested?
- Synchronized Cardiac Support with the icor kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2025to Sep 2026
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent signed and dated by study patient/legal representative and investigator/authorised physician
- Minimum age of 18 years
- Patients in cardiogenic shock
- Cardiogenic shock is defined as:
- Systolic blood pressure < 90 mmHg for at least 30 min
- Inotropes and/or vasopressors are needed to maintain systolic blood pressure > 90 mmHg
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- Clinical signs of heart insufficiency with pulmonary congestion
- Signs of end organ hypoperfusion with at least one of the following criteria:
- Cold, damp skin or extremities
- Oliguria (≤ 30 mL/h)
- Serum lactate > 3.0 mmol/L
Who cannot join
- In case of female patients: pregnancy or lactation period
- Participation in an interventional clinical study during the preceding 30 days
- Previous participation in the same study
- Age > 85 years
- Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) > 30 min
- No flow time > 5 min
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- Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture)
- Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.)
- Fever (Body temperature > 38.0 °C) or other evidence of sepsis
- Onset of cardiogenic shock > 6 h before enrolment
- Lactate > 16 mmol/L
- Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters
- Contra-indications for anticoagulation
- Contra-indication for VA ECMO, e.g. unrecoverable heart and not a candidate for transplant or VAD
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites
Krankenhaus Buchholz und Winsen gGmbH
Buchholz, 21244
Hertting Klaus, Dr med, Klaus.Hertting@krankenhaus-buchholz.de
Elisabeth-Krankenhaus Essen GmbH
Essen, 45138
Voigt Ingo, Dr med, I.Voigt@contilia.de
About this study
Official title: Evaluating the Efficacy and Safety of the Synchronized Cardiac Support Treatment with the Icor Kit in Patients with Cardiogenic Shock - a Pivotal Study (Pulse SE)
The study aims to investigate the safety and efficacy of the Synchronized Cardiac Support treatment wit the icor kit and the Xenios console with modified sensor box ECG and Software Version 3.2.4
Read the detailed description
The current study hypothesizes that The SCS treatment with the icor kit provides sufficient support for cardiocirculatory function as indicated by a significant lactate reduction 24 hours on SCS treatment versus before treatment start.
Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support.
Synchronized Cardiac Support describes an electrocardiogram (ECG)- triggered pulsatile VA-ECMO based on R-wave detection. During diastole the pump speed and thus the flow is increased and during systole the pump flow is been set on a relative minimum. This provides a mechanical circulatory support pulse with oxygenated blood during diastole.
The Synchronized Cardiac Support Treatment is used in a standard VA ECMO configuration by two femoral single vessel cannulas. Patients following cardiac resuscitation will undergo targeted temperature management 32- 36°C according to guideline.
The Duration of Treatment can be up to 14 days.
- Conditions
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation, ECLS, VA ECMO
- Being tested
- Synchronized Cardiac Support with the icor kit
- Keywords
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Synchronized Cardiac Support, ECLS, VA ECMO
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronized Cardiac Support with the icor kitDevice
Also called Synchronized Cardiac Support (icor)
Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support (SCS).
| Study group | Role | What they receive |
|---|---|---|
| venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization | Other | Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support (SCS). Receives: Device: Synchronized Cardiac Support with the icor kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiocirculatory stabilization and end-organ perfusion
measured by the Change in Lactate Level
Measured: up to 14 days
Secondary outcomes (5)
Cardiocirculatory stabilization and end-organ perfusion
measured by the following parameter: Mean Arterial Pressure, Catecholamine Support, Cardiac Index, Cardiac Output and Cardiac Afterload
Measured: up to 14 days
Maintain gas exchange
measured by the following parameter: Blood Gas Analysis and Mechanical Ventilation
Measured: up to 14 days
Extracorporeal Life Support (ECLS) Performance
measured by the following parameter: Blood Flow, Blood Pressure, Synchronization of the patient's heartbeat, Intra-hospital transportation
Measured: up to 14 days
Maintain renal function
measured by the following parameter: Fluid Balance, Renal Replacement Therapy, Creatinine and eGRF
Measured: up to 14 days
Thermoregulation
measured by the the Body Temperature
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study startSep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xenios AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ingo Voigt, Dr., Principal investigator, Elisabeth-Krankenhaus Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106491
- Sponsor's protocol ID
- CS-SCS-01-DE
- Acronym
- PulseSE
- Status last verified
- Mar 2025
- First submitted
- 5 Oct 2021
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of the Synchronized Cardiac Support Treatment with the Icor Kit in Patients with Cardiogenic Shock - a Pivotal Study (Pulse SE)
- ClinicalTrials.gov ID
- NCT05106491
- Acronym / sponsor ID
- PulseSE / CS-SCS-01-DE
- Conditions
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation, ECLS, VA ECMO
- Keywords
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Synchronized Cardiac Support, ECLS, VA ECMO
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Xenios AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 3 Nov 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.
The study aims to investigate the safety and efficacy of the Synchronized Cardiac Support treatment wit the icor kit and the Xenios console with modified sensor box ECG and Software Version 3.2.4
Detailed description
The current study hypothesizes that The SCS treatment with the icor kit provides sufficient support for cardiocirculatory function as indicated by a significant lactate reduction 24 hours on SCS treatment versus before treatment start.
Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support.
Synchronized Cardiac Support describes an electrocardiogram (ECG)- triggered pulsatile VA-ECMO based on R-wave detection. During diastole the pump speed and thus the flow is increased and during systole the pump flow is been set on a relative minimum. This provides a mechanical circulatory support pulse with oxygenated blood during diastole.
The Synchronized Cardiac Support Treatment is used in a standard VA ECMO configuration by two femoral single vessel cannulas. Patients following cardiac resuscitation will undergo targeted temperature management 32- 36°C according to guideline.
The Duration of Treatment can be up to 14 days.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization | Other | Device: Synchronized Cardiac Support with the icor kitPatients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support (SCS). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Informed consent signed and dated by study patient/legal representative and investigator/authorised physician
- Minimum age of 18 years
- Patients in cardiogenic shock
- Cardiogenic shock is defined as:
- Signs of end organ hypoperfusion with at least one of the following criteria:
Key exclusion criteria (14 listed)
- In case of female patients: pregnancy or lactation period
- Participation in an interventional clinical study during the preceding 30 days
- Previous participation in the same study
- Age > 85 years
- Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) > 30 min
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 |
|---|---|---|
| Synchronized Cardiac Support with the icor kitAlso: Synchronized Cardiac Support (icor)Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support (SCS). | Device | venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization |
Primary outcome
Cardiocirculatory stabilization and end-organ perfusion
Time frame: up to 14 days
measured by the Change in Lactate Level
5 secondary outcomes
Cardiocirculatory stabilization and end-organ perfusion
Time frame: up to 14 days
Maintain gas exchange
Time frame: up to 14 days
Extracorporeal Life Support (ECLS) Performance
Time frame: up to 14 days
Maintain renal function
Time frame: up to 14 days
Thermoregulation
Time frame: up to 14 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 14 Mar 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.
Ingo Voigt, Dr. principal investigator
Elisabeth-Krankenhaus Essen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synchronized Cardiac Support with the icor kit in people with Cardiogenic Shock and Extracorporeal Membrane Oxygenation, run by Xenios AG at 2 sites in Germany.
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 11 inclusion and 14 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: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 Anja Derlet-Savoia, Dr. (+49 6172 2686648, anja.derlet@freseniusmedicalcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiocirculatory stabilization and end-organ perfusion (time frame: up to 14 days). 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 14 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.