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Clinical Trials in Germany / NCT05106491
Starting soon Not applicable

Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients

NCT05106491 · tracked via the Priya Life Science Germany tracker
Sponsor
Phase
Not applicable
Started
2025-09
Last updated
2025-03-14

Condition(s) studied

Cardiogenic ShockExtracorporeal Membrane OxygenationECLSVA ECMO

Investigational drug(s) / intervention(s)

Synchronized Cardiac Support with the icor kit

Synchronized Cardiac Support with the icor kit: Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support (SCS).

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Krankenhaus Buchholz und Winsen gGmbH Buchholz Germany
Elisabeth-Krankenhaus Essen GmbH Essen Germany

More Xenios AG trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05106491 on ClinicalTrials.gov ↗ ← All trials in Germany