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Not yet recruiting NCT05106491

Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients

No phase Interventional Cardiogenic Shock Extracorporeal Membrane Oxygenation ECLS VA ECMO

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Synchronized Cardiac Support with the icor kit.
Who it may be relevant to
Registry conditions: Cardiogenic Shock, Extracorporeal Membrane Oxygenation, ECLS, VA ECMO. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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.

Interventions

  • 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).

Primary outcome measures

  • Cardiocirculatory stabilization and end-organ perfusion [Time frame: up to 14 days]
Secondary outcome measures (5)
  • Cardiocirculatory stabilization and end-organ perfusion [Time frame: up to 14 days]
  • Maintain gas exchange [Time frame: up to 14 days]
  • Extracorporeal Life Support (ECLS) Performance [Time frame: up to 14 days]
  • Maintain renal function [Time frame: up to 14 days]
  • Thermoregulation [Time frame: up to 14 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

Germany · 2 centers
  • Krankenhaus Buchholz und Winsen gGmbH — Buchholz
  • Elisabeth-Krankenhaus Essen GmbH — Essen

Identifiers

NCT: NCT05106491 · CS-SCS-01-DE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗