Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients

NCT05106491 | Not Yet Recruiting DMC

• 1 other identifier: CS-SCS-01-DE
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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

Conditions

Cardiogenic Shock; Extracorporeal Membrane Oxygenation; ECLS; VA ECMO

Keywords

Cardiogenic Shock; Extracorporeal Membrane Oxygenation; Synchronized Cardiac Support; ECLS; VA ECMO

Outcome Measures

Primary Outcomes (1)

• Cardiocirculatory stabilization and end-organ perfusion

  measured by the Change in Lactate Level

  up to 14 days

Secondary Outcomes (5)

• Cardiocirculatory stabilization and end-organ perfusion

  up to 14 days

• Maintain gas exchange

  up to 14 days

• Extracorporeal Life Support (ECLS) Performance

  up to 14 days

• Maintain renal function

  up to 14 days

• Thermoregulation

  up to 14 days

Other Outcomes (1)

• Safety Variables

  up to 14 days

Study Arms (1)

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).

Device: Synchronized Cardiac Support with the icor kit

Interventions

Synchronized Cardiac Support with the icor kit DEVICE

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

Also known as: Synchronized Cardiac Support (icor)

venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Xenios AG: lead

Study Sites (2)

Krankenhaus Buchholz und Winsen gGmbH

Buchholz, 21244, Germany

Location

Elisabeth-Krankenhaus Essen GmbH

Essen, 45138, Germany

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Ingo Voigt, Dr.

  Elisabeth-Krankenhaus Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anja Derlet-Savoia, Dr.

CONTACT

+49 6172 2686648; anja.derlet@freseniusmedicalcare.com

Celina Erfle

CONTACT

+49 6172 2686809; celina.erfle@freseniusmedicalcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 3, 2021
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

DE (2)