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

Sponsor

Xenios AG (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05106491

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Cardiogenic Shock Extracorporeal Membrane Oxygenation ECLS VA ECMO	Device: Synchronized Cardiac Support with the icor kit	N/A

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 Design

Study Type:

Interventional

Anticipated 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)

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Outcome Measures

Primary Outcome Measures

Cardiocirculatory stabilization and end-organ perfusion [up to 14 days]
measured by the Change in Lactate Level

Secondary Outcome Measures

Cardiocirculatory stabilization and end-organ perfusion [up to 14 days]
measured by the following parameter: Mean Arterial Pressure, Catecholamine Support, Cardiac Index, Cardiac Output and Cardiac Afterload
Maintain gas exchange [up to 14 days]
measured by the following parameter: Blood Gas Analysis and Mechanical Ventilation
Extracorporeal Life Support (ECLS) Performance [up to 14 days]
measured by the following parameter: Blood Flow, Blood Pressure, Synchronization of the patient's heartbeat, Intra-hospital transportation
Maintain renal function [up to 14 days]
measured by the following parameter: Fluid Balance, Renal Replacement Therapy, Creatinine and eGRF
Thermoregulation [up to 14 days]
measured by the the Body Temperature

Other Outcome Measures

Safety Variables [up to 14 days]
Severe adverse events, i.e. Hemolysis Bleeding Severe adverse device events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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:
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