Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients

Cardiogenic Shock Clinical Trial

— PulseSE  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05106491
• Other study ID #: CS-SCS-01-DE
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: Anja Derlet-Savoia, Dr.
• Phone: +49 6172 608 2801
• Email: anja.derlet-savoia[@]fmc-ag.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Extracorporeal Membrane Oxygenation
• Shock
• Shock, Cardiogenic

Intervention

Device:
• 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).

Locations

Country	Name	City	State
Germany	Krankenhaus Buchholz und Winsen gGmbH	Buchholz
Germany	Elisabeth-Krankenhaus Essen GmbH	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Xenios AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Variables	Severe adverse events, i.e. Hemolysis Bleeding; Severe adverse device events	up to 14 days
Primary	Cardiocirculatory stabilization and end-organ perfusion	measured by the Change in Lactate Level	up to 14 days
Secondary	Cardiocirculatory stabilization and end-organ perfusion	measured by the following parameter: Mean Arterial Pressure, Catecholamine Support, Cardiac Index, Cardiac Output and Cardiac Afterload	up to 14 days
Secondary	Maintain gas exchange	measured by the following parameter: Blood Gas Analysis and Mechanical Ventilation	up to 14 days
Secondary	Extracorporeal Life Support (ECLS) Performance	measured by the following parameter: Blood Flow, Blood Pressure, Synchronization of the patient's heartbeat, Intra-hospital transportation	up to 14 days
Secondary	Maintain renal function	measured by the following parameter: Fluid Balance, Renal Replacement Therapy, Creatinine and eGRF	up to 14 days
Secondary	Thermoregulation	measured by the the Body Temperature	up to 14 days