Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients

NCT ID: NCT05106491

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-09-30

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization

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

Group Type: OTHER

Synchronized Cardiac Support with the icor kit

Intervention Type: DEVICE

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

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

Synchronized Cardiac Support (icor)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xenios AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingo Voigt, Dr.

Role: PRINCIPAL_INVESTIGATOR

Elisabeth-Krankenhaus Essen

Locations

Krankenhaus Buchholz und Winsen gGmbH

Buchholz, , Germany

Elisabeth-Krankenhaus Essen GmbH

Essen, , Germany

Countries

Germany

Central Contacts

Anja Derlet-Savoia, Dr.

Role: CONTACT

anja.derlet@freseniusmedicalcare.com

+49 6172 2686648

Celina Erfle

Role: CONTACT

celina.erfle@freseniusmedicalcare.com

+49 6172 2686809

Facility Contacts

Hertting Klaus, Dr med

Role: primary

Klaus.Hertting@krankenhaus-buchholz.de

Voigt Ingo, Dr med

Role: primary

I.Voigt@contilia.de

Other Identifiers

CS-SCS-01-DE

Identifier Type: -

Identifier Source: org_study_id