Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients (PulseSE)

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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Extracorporeal Membrane Oxygenation; Cardiogenic Shock; ECLS; VA ECMO
• Intervention / Treatment: Device: Synchronized Cardiac Support with the icor kit

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.

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anja Derlet-Savoia, Dr.; Phone Number: +49 6172 2686648; Email: anja.derlet@freseniusmedicalcare.com
• Study Contact Backup: Name: Celina Erfle; Phone Number: +49 6172 2686809; Email: celina.erfle@freseniusmedicalcare.com

Study Locations

• Germany
  • Buchholz, Germany, 21244
    • Krankenhaus Buchholz und Winsen gGmbH
    • Contact: Hertting Klaus, Dr med; Email: Klaus.Hertting@krankenhaus-buchholz.de
  • Essen, Germany, 45138
    • Elisabeth-Krankenhaus Essen GmbH
    • Contact: Voigt Ingo, Dr med; Email: I.Voigt@contilia.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).	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).; Other Names: Synchronized Cardiac Support (icor)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiocirculatory stabilization and end-organ perfusion	measured by the Change in Lactate Level	up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Maintain gas exchange	measured by the following parameter: Blood Gas Analysis and Mechanical Ventilation	up to 14 days
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
Maintain renal function	measured by the following parameter: Fluid Balance, Renal Replacement Therapy, Creatinine and eGRF	up to 14 days
Thermoregulation	measured by the the Body Temperature	up to 14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Variables	Severe adverse events, i.e. Hemolysis Bleeding; Severe adverse device events	up to 14 days

Collaborators and Investigators

• Sponsor: Xenios AG
• Investigators: Principal Investigator: Ingo Voigt, Dr., Elisabeth-Krankenhaus Essen

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Cardiogenic Shock; Extracorporeal Membrane Oxygenation; Synchronized Cardiac Support; ECLS; VA ECMO
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Shock, Cardiogenic; Shock
• Other Study ID Numbers: CS-SCS-01-DE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No