Status:

ENROLLING_BY_INVITATION

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

Lead Sponsor:

Cardiaccs AS

Collaborating Sponsors:

European Commission

Conditions:

Cardiac Disease

Myocardial Dysfunction

Eligibility:

All Genders

19-99 years

Phase:

NA

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 transthorac...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • Esophageal disease
  • Atrial fibrillation
  • Pregnancy

Key Trial Info

Start Date :

October 25 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2025

Estimated Enrollment :

38 Patients enrolled

Trial Details

Trial ID

NCT04886934

Start Date

October 25 2021

End Date

March 1 2025

Last Update

February 16 2024

Active Locations (1)

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1

Oslo University Hospital

Oslo, Norway, 4950