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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiac Disease; Myocardial Dysfunction
• Intervention / Treatment: Device: CS1 System

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 Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 4950
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Peak Systolic Velocity (PSV) after increasing heart rate by 25 percent	Correlation between relative changes in PSVs measured by CS1 and echocardiography	After surgery: before extubation, while patient is in the intensive care unit (ICU)
Change from Baseline PSV after increasing heart rate by 25 percent	Correlation between relative changes in PSVs measured by CS1 and echocardiography	After surgery: after extubation and removal of drains, before patient is transferred from ICU to general ward

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Incidence of non-serious and serious adverse events rated for causality	Up to 30 days after surgery
Adverse Device Effects	Incidence of non-serious and serious adverse device-related effects	Up to removal of device at a maximum of 7 days after surgery
Device Deficiencies	Incidence of device deficiencies	Up to removal of device at a maximum of 7 days after surgery

Collaborators and Investigators

• Sponsor: Cardiaccs AS
• Collaborators: European Commission

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 2020-004776-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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