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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05106491
Recruitment Status : Not yet recruiting
First Posted : November 3, 2021
Last Update Posted : July 28, 2022
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH ( Xenios AG )

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

Condition or disease Intervention/treatment Phase
Cardiogenic Shock Extracorporeal Membrane Oxygenation ECLS VA ECMO Device: Synchronized Cardiac Support with the icor kit Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
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)
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock


Intervention Details:
  • 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 Name: Synchronized Cardiac Support (icor)


Primary Outcome Measures :
  1. Cardiocirculatory stabilization and end-organ perfusion [ Time Frame: up to 14 days ]
    measured by the Change in Lactate Level


Secondary Outcome Measures :
  1. Cardiocirculatory stabilization and end-organ perfusion [ Time Frame: up to 14 days ]
    measured by the following parameter: Mean Arterial Pressure, Catecholamine Support, Cardiac Index, Cardiac Output and Cardiac Afterload

  2. Maintain gas exchange [ Time Frame: up to 14 days ]
    measured by the following parameter: Blood Gas Analysis and Mechanical Ventilation

  3. Extracorporeal Life Support (ECLS) Performance [ Time Frame: up to 14 days ]
    measured by the following parameter: Blood Flow, Blood Pressure, Synchronization of the patient's heartbeat, Intra-hospital transportation

  4. Maintain renal function [ Time Frame: up to 14 days ]
    measured by the following parameter: Fluid Balance, Renal Replacement Therapy, Creatinine and eGRF

  5. Thermoregulation [ Time Frame: up to 14 days ]
    measured by the the Body Temperature


Other Outcome Measures:
  1. Safety Variables [ Time Frame: up to 14 days ]
    1. Severe adverse events, i.e. Hemolysis Bleeding
    2. Severe adverse device events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05106491


Contacts
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Contact: Anja Derlet-Savoia, Dr. +49 6172 608 2801 anja.derlet-savoia@fmc-ag.com
Contact: Celina Erfle +49 6172 609 93208 celina.erfle@fmc-ag.com

Sponsors and Collaborators
Xenios AG
Investigators
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Principal Investigator: Ingo Voigt, Dr. Elisabeth-Krankenhaus Essen
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Responsible Party: Xenios AG
ClinicalTrials.gov Identifier: NCT05106491    
Other Study ID Numbers: CS-SCS-01-DE
First Posted: November 3, 2021    Key Record Dates
Last Update Posted: July 28, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fresenius Medical Care Deutschland GmbH ( Xenios AG ):
Cardiogenic Shock
Extracorporeal Membrane Oxygenation
Synchronized Cardiac Support
ECLS
VA ECMO
Additional relevant MeSH terms:
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Shock, Cardiogenic
Shock
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Infarction
Ischemia
Necrosis