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Temporary Epicardial Pace Wire With Integrated Sensor for Continuous Postoperative Monitoring of Myocardial Function

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ClinicalTrials.gov Identifier: NCT04886934
Recruitment Status : Enrolling by invitation
First Posted : May 14, 2021
Last Update Posted : January 12, 2023
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Cardiaccs AS

Study Description
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Brief Summary:

Transesophageal echocardiography is used to monitor cardiac wall motion at various time points during open-heart surgery. After surgery, the measurements are made at various time points by transthoracic echocardiography.

The CS1 system enables continuous, direct measurement of cardiac wall motion. This is achieved through use of temporary pacemaker wires incorporating a motion detector called an accelerometer. Use of TMEs during and after open-heart surgery is part of the normal clinical routine. Continuous monitoring of cardiac wall motion during and after surgery can quickly highlight the need for medical intervention with cardiac drugs and allow very early detection of potentially serious complications leading to abnormal cardiac wall motion.

Cardiac wall motion activity registered by the CS1 system and echocardiography at specific time points during and after surgery will be analyzed to see how well they compare.


Condition or disease Intervention/treatment Phase
Cardiac Disease Myocardial Dysfunction Device: CS1 System Not Applicable

Detailed Description:

Echocardiography is currently the most important and most widely used tool in cardiology besides electrocardiography (ECG). It is reliable for assessing all stages of cardiovascular disease, and it is commonly used to detect heart (cardiac) wall motion dysfunction during and after open-heart surgery.

During open-heart surgery, transesophageal echocardiography (when the echocardiography sensor is introduced into the esophagus) is used to monitor cardiac wall motion at various time points during surgery. After surgery, the measurements are made at various time points by transthoracic echocardiography (when the echocardiography sensor is placed on the chest wall).

Use of the CS1 system enables continuous, direct measurements of cardiac wall motion. This is achieved through use of temporary pacemaker wires (also called temporary myocardial electrodes or TMEs) incorporating a motion detector called an accelerometer. Use of TMEs during and after open-heart surgery is part of the normal clinical routine. Continuous monitoring of cardiac wall motion during the surgery and the post-surgical recovery period can, for example, quickly highlight the need for medical intervention with cardiac drugs and allow very early detection of potentially serious complications such as ischemia (heart muscle is not receiving enough oxygen) and myocardial dysfunction (cardiac wall motion appears abnormal).

The key feature of the CS1 system is that the cardiac wall motion activity registered by the novel TMEs incorporating the accelerometer are displayed visually on a standard medical monitor and synchronized with the patient's ECG data. These data can easily be viewed by medical staff to check if the patient's condition is satisfactory or whether medical intervention is needed.

In the study, the CS1 system will be used in addition to the standard monitoring procedures that include ECG, blood pressures and intermittent echocardiography. Cardiac wall motion activity registered by the CS1 system and echocardiography at specific time points during and after surgery will be analyzed to see how well they compare.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Open Clinical Investigation to Assess Performance of a Temporary Epicardial Pace Wire With Integrated Sensor for Continuous Postoperative Monitoring of Myocardial Function After Heart Surgery Compared to Ultrasound
Actual Study Start Date : October 25, 2021
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arms and Interventions
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Arm Intervention/treatment
Experimental: Safety and clinical performance of the CS1 system
Placement of the CS1 device on the left ventricle and externalization of the associated leads through the chest wall during open-heart surgery.
 Device: CS1 System
Placement of CS1, a temporary bipolar myocardial electrode (TME) with an integrated motion sensor (accelerometer), on the left ventricle and externalization of the associated leads through the chest wall during open-heart surgery. CS1 will remain in place for up to 7 days after surgery and closure of the chest wall.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline Peak Systolic Velocity (PSV) after increasing heart rate by 25 percent [ Time Frame: After surgery: before extubation, while patient is in the intensive care unit (ICU) ]
    Correlation between relative changes in PSVs measured by CS1 and echocardiography

  2. Change from Baseline PSV after increasing heart rate by 25 percent [ Time Frame: After surgery: after extubation and removal of drains, before patient is transferred from ICU to general ward ]
    Correlation between relative changes in PSVs measured by CS1 and echocardiography


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to 30 days after surgery ]
    Incidence of non-serious and serious adverse events rated for causality

  2. Adverse Device Effects [ Time Frame: Up to removal of device at a maximum of 7 days after surgery ]
    Incidence of non-serious and serious adverse device-related effects

  3. Device Deficiencies [ Time Frame: Up to removal of device at a maximum of 7 days after surgery ]
    Incidence of device deficiencies


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with heart disease requiring surgery
  2. Above 18 years
  3. Patients suitable for study participation without safety concerns based on the Investigator's evaluation of medical history and physical examination.
  4. The patient must be able to understand the aims and objectives of the trial, willing and able to comply with all study related procedures
  5. The patient must be willing and able to provide written informed consent prior to participation in the clinical investigation
  6. The patient agrees to abstain from enrollment in any other clinical investigation for the duration of the study

Exclusion Criteria:

  1. Esophageal disease
  2. Atrial fibrillation
  3. Pregnancy
Contacts and Locations
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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): NCT04886934


Locations
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Norway
Oslo University Hospital
Oslo, Norway, 4950
Sponsors and Collaborators
Cardiaccs AS
European Commission
More Information
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Responsible Party: Cardiaccs AS
ClinicalTrials.gov Identifier: NCT04886934    
Other Study ID Numbers: 2020-004776-17
First Posted: May 14, 2021    Key Record Dates
Last Update Posted: January 12, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases