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CardioSenseSystem Compared Study Regarding Efficacy and Safety in the Monitoring of ECG

NCT03610529 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-09-11

No results posted yet for this study

Summary

This is a prospective, controlled, comparative clinical trial of a new ECG monitoring system CardioSenseSystem prior CE marking. The aim of the study is to demonstrate that the CardioSenseSystem's cable-free ECG monitoring system (investigational device) is equivalent or better than traditional and accepted industry standard for cable-based ECG monitoring system (control device). In this study accepted industry standard is Philips Intellivue. In order to investigate this, the study will measure ECG monitoring interruptions, management time and alarm performance. The study population will consist of sixty (60) adult subjects requiring ECG and that are fulfilling the eligibility criteria for study participation. The subjects will be using both the investigational device and the control device simultaneous for measuring data loss, management time and alarm function up to 24 hours.

Conditions

  • Cardiac Arrythmias
  • Unstable Angina
  • Heart Valve Disorders
  • Disorder of Aorta

Interventions

DEVICE

CardioSenseSystem

CardioSensySystem is a novel wireless ECG monitoring system developed by Novosense AB for monitoring of ECG in health care departments.

DEVICE

Philips Intellivue

Philips Intellivue in an established ECG monitoring system used at the clinical investigational device.

Sponsors & Collaborators

  • Novosense AB

    lead INDUSTRY

Principal Investigators

  • Rikard Linnér, MD PhD EDIC · Skane University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2020-12-31
Completion
2020-12-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03610529 on ClinicalTrials.gov