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ClinicalTrials.gov ID

NCT05106491

Lead Sponsor

Xenios AGINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

21Estimated

Last Update Posted

Mar 14, 2025Actual

Start Date

Sep 2025Estimated

Primary Completion Date

Sep 2026Estimated

Completion Date

Sep 2026Estimated

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)

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.

• Cardiogenic Shock
• Extracorporeal Membrane Oxygenation
• ECLS
• VA ECMO

• Synchronized Cardiac Support with the icor kit

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Device Feasibility

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Xenios AGINDUSTRY

I.Voigt@contilia.de