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NCT05106491 | NOT YET RECRUITING | Cardiogenic Shock

Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients
Sponsor:

Xenios St.

Brief 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

Condition or disease

Cardiogenic Shock

Extracorporeal Membrane Oxygenation

ECLS

And ecmo

Intervention/treatment

Synchronized Cardiac Support with the icor kit

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 21 participants
Masking : NONE
Primary Purpose : DEVICE_FEASIBILITY
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)
Actual Study Start Date : 2025-09
Estimated Primary Completion Date : 2026-09
Estimated Study Completion Date : 2026-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Informed consent signed and dated by study patient/legal representative and investigator/authorised physician
  • 2. Minimum age of 18 years
  • 3. Patients in cardiogenic shock
  • 4. Cardiogenic shock is defined as
    • 1. Systolic blood pressure \< 90 mmHg for at least 30 min
    • 2. Inotropes and/or vasopressors are needed to maintain systolic blood pressure \> 90 mmHg
    • 3. Clinical signs of heart insufficiency with pulmonary congestion
    • 5. Signs of end organ hypoperfusion with at least one of the following criteria
      • 1. Cold, damp skin or extremities
      • 2. Oliguria (≤ 30 mL/h)
      • 6. Serum lactate \> 3.0 mmol/L
      Exclusion Criteria
      • 1. In case of female patients: pregnancy or lactation period
      • 2. Participation in an interventional clinical study during the preceding 30 days
      • 3. Previous participation in the same study
      • 4. Age \> 85 years
      • 5. Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) \> 30 min
      • 6. No flow time \> 5 min
      • 7. Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture)
      • 8. Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.)
      • 9. Fever (Body temperature \> 38.0 °C) or other evidence of sepsis
      • 10. Onset of cardiogenic shock \> 6 h before enrolment
      • 11. Lactate \> 16 mmol/L
      • 12. Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters
      • 13. Contra-indications for anticoagulation
      • 14. Contra-indication for VA ECMO, e.g. unrecoverable heart and not a candidate for transplant or VAD
Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients

Location Details

NCT05106491

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Germany,

Buchholz and Winsen gGmbH Hospital

Buchholz, Germany, 21244

Not yet recruiting

Germany,

Elisabeth-Kilkenhaus Essen GmbH

Essen, Germany, 45138