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

Primary Purpose

Cardiogenic Shock, Extracorporeal Membrane Oxygenation, ECLS

Status

Not yet recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Synchronized Cardiac Support with the icor kit

About this trial

This is an interventional device feasibility trial for Cardiogenic Shock focused on measuring Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Synchronized Cardiac Support, ECLS, VA ECMO

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Informed consent signed and dated by study patient/legal representative and investigator/authorised physician
Minimum age of 18 years
Patients in cardiogenic shock
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
Signs of end organ hypoperfusion with at least one of the following criteria:
1. Cold, damp skin or extremities
2. Oliguria (≤ 30 mL/h)
Serum lactate > 3.0 mmol/L

Exclusion Criteria:

In case of female patients: pregnancy or lactation period
Participation in an interventional clinical study during the preceding 30 days
Previous participation in the same study
Age > 85 years
Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) > 30 min
No flow time > 5 min
Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture)
Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.)
Fever (Body temperature > 38.0 °C) or other evidence of sepsis
Onset of cardiogenic shock > 6 h before enrolment
Lactate > 16 mmol/L
Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters
Contra-indications for anticoagulation
Contra-indication for VA ECMO, e.g. unrecoverable heart and not a candidate for transplant or VAD

Sites / Locations

Krankenhaus Buchholz und Winsen gGmbH
Elisabeth-Krankenhaus Essen GmbH

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization

Arm Description

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

Outcomes

Primary Outcome Measures

Cardiocirculatory stabilization and end-organ perfusion

measured by the Change in Lactate Level

Secondary Outcome Measures

Cardiocirculatory stabilization and end-organ perfusion

measured by the following parameter: Mean Arterial Pressure, Catecholamine Support, Cardiac Index, Cardiac Output and Cardiac Afterload

Maintain gas exchange

measured by the following parameter: Blood Gas Analysis and Mechanical Ventilation

Extracorporeal Life Support (ECLS) Performance

measured by the following parameter: Blood Flow, Blood Pressure, Synchronization of the patient's heartbeat, Intra-hospital transportation

Maintain renal function

measured by the following parameter: Fluid Balance, Renal Replacement Therapy, Creatinine and eGRF

Thermoregulation

measured by the the Body Temperature

Full Information

NCT ID

NCT05106491

First Posted

October 5, 2021

Last Updated

February 19, 2023

Sponsor

Xenios AG

1. Study Identification

Unique Protocol Identification Number

NCT05106491

Brief Title

Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 2023 (Anticipated)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xenios AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiogenic Shock, Extracorporeal Membrane Oxygenation, ECLS, VA ECMO

Keywords

Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Synchronized Cardiac Support, ECLS, VA ECMO

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization

Arm Type

Other

Arm Description

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

Intervention Name(s)

Synchronized Cardiac Support with the icor kit

Other Intervention Name(s)

Synchronized Cardiac Support (icor)

Intervention Description

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

Primary Outcome Measure Information:

Title

Cardiocirculatory stabilization and end-organ perfusion

Description

measured by the Change in Lactate Level

Time Frame

up to 14 days

Secondary Outcome Measure Information:

Title

Cardiocirculatory stabilization and end-organ perfusion

Description

measured by the following parameter: Mean Arterial Pressure, Catecholamine Support, Cardiac Index, Cardiac Output and Cardiac Afterload

Time Frame

up to 14 days

Title

Maintain gas exchange

Description

measured by the following parameter: Blood Gas Analysis and Mechanical Ventilation

Time Frame

up to 14 days

Title

Extracorporeal Life Support (ECLS) Performance

Description

measured by the following parameter: Blood Flow, Blood Pressure, Synchronization of the patient's heartbeat, Intra-hospital transportation

Time Frame

up to 14 days

Title

Maintain renal function

Description

measured by the following parameter: Fluid Balance, Renal Replacement Therapy, Creatinine and eGRF

Time Frame

up to 14 days

Title

Thermoregulation

Description

measured by the the Body Temperature

Time Frame

up to 14 days

Other Pre-specified Outcome Measures:

Title

Safety Variables

Description

Severe adverse events, i.e. Hemolysis Bleeding Severe adverse device events

Time Frame

up to 14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Informed consent signed and dated by study patient/legal representative and investigator/authorised physician Minimum age of 18 years Patients in cardiogenic shock Cardiogenic shock is defined as: Systolic blood pressure < 90 mmHg for at least 30 min Inotropes and/or vasopressors are needed to maintain systolic blood pressure > 90 mmHg Clinical signs of heart insufficiency with pulmonary congestion Signs of end organ hypoperfusion with at least one of the following criteria: Cold, damp skin or extremities Oliguria (≤ 30 mL/h) Serum lactate > 3.0 mmol/L Exclusion Criteria: In case of female patients: pregnancy or lactation period Participation in an interventional clinical study during the preceding 30 days Previous participation in the same study Age > 85 years Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) > 30 min No flow time > 5 min Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture) Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.) Fever (Body temperature > 38.0 °C) or other evidence of sepsis Onset of cardiogenic shock > 6 h before enrolment Lactate > 16 mmol/L Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters Contra-indications for anticoagulation Contra-indication for VA ECMO, e.g. unrecoverable heart and not a candidate for transplant or VAD

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anja Derlet-Savoia, Dr.

Phone

+49 6172 608 2801

anja.derlet-savoia@fmc-ag.com

First Name & Middle Initial & Last Name or Official Title & Degree

Celina Erfle

Phone

+49 6172 609 93208

celina.erfle@fmc-ag.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ingo Voigt, Dr.

Organizational Affiliation

Elisabeth-Krankenhaus Essen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Krankenhaus Buchholz und Winsen gGmbH

City

Buchholz

ZIP/Postal Code

21244

Country

Germany

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hertting Klaus, Dr med

Klaus.Hertting@krankenhaus-buchholz.de

Facility Name

Elisabeth-Krankenhaus Essen GmbH

City

Essen

ZIP/Postal Code

45138

Country

Germany

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Voigt Ingo, Dr med

I.Voigt@contilia.de

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients

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