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

NCT04886934 | Unknown

• 1 other identifier: 2020-004776-17
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disease; Myocardial Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Adverse Events

  Up to 30 days after surgery

• Adverse Device Effects

  Up to removal of device at a maximum of 7 days after surgery

• Device Deficiencies

  Up to removal of device at a maximum of 7 days after surgery

Study Arms (1)

Safety and clinical performance of the CS1 system

EXPERIMENTAL

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

Interventions

CS1 System DEVICE

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.

Safety and clinical performance of the CS1 system

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Esophageal disease
• Atrial fibrillation
• Pregnancy

Sponsors & Collaborators

• Cardiaccs AS: lead
• European Commission: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 4950, Norway

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 14, 2021
• Study Start: October 25, 2021
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: February 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)