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

NCT03610529 | Unknown

• 3 other identifiers: NovoECG5.1-2018-183432018/9
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ECG Monitoring; Controlled; Comparative; Clinical trial

Outcome Measures

Primary Outcomes (1)

• Lost of monitoring data

  Compare time of interruptions in the monitoring system between the investigational device and the control device.

  During 24 hour per subject

Secondary Outcomes (4)

• Management time

  During 24 hour per subject

• Number of correct yellow and red alarm

  During 24 hour per subject

• Number of false yellow and red alarm

  During 24 hour per subject

• Incidence and severity of Averse Events

  During 24 hour per subject

Study Arms (2)

ECG monitoring system CardioSenseSystem group

EXPERIMENTAL

Device: CardioSenseSystem

ECG monitoring system Philips Intellivue

ACTIVE COMPARATOR

Device: Philips Intellivue

Interventions

CardioSenseSystem DEVICE

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

ECG monitoring system CardioSenseSystem group

Philips Intellivue DEVICE

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

ECG monitoring system Philips Intellivue

Eligibility Criteria

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

You may qualify if:

• Male or female at least 18 years old.
• Patient hospitalized at the investigational site and in need of ECG monitoring.
• Patient with expected alarms during the 24 hours ECG monitoring.
• Patient who has been informed of the clinical trials purpose, limitations and relevance, and who has voluntarily agreed to participation in the clinical trial by signing the informed consent form.

You may not qualify if:

• Patient with burns.
• Patient with known allergy or sensitivity to any of the compositions in CardioPatch.
• Patient with infection in the area where the electrodes are to be placed.
• Patient with fragile skin (eg after prolonged cortisone treatment).
• Patient with open sternum / sternum (eg severe heart failure postoperatively) or treatment for infection of the sternum.
• Patient with mechanical auxiliary heart or ECMO.
• Patient with implantable defibrillator.
• Severely ill patient during end of life.
• Patient participating in any other clinical trial.
• Patient where the investigator judge that participation may be risky for the patient or obstruct or interfere the implementation of the trial as approved.

Sponsors & Collaborators

• Novosense AB: lead

Study Sites (1)

VO Thorax o Kärl, Region Skåne

Lund, Entrégatan 7, SE-222 41, Sweden

Location

Related Links

• Sponsors website

MeSH Terms

Conditions

Angina, Unstable; Heart Valve Diseases; Aortic Diseases

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rikard Linnér, MD PhD EDIC

  Skane University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Tilly

CONTACT

+46709905725; jonas.tilly@novosense.se

Study Design

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

Model Details: The study participants will be using both the experimental device and the control device simultaneously throughout the study participation. The participant will thereby act as its own control.

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 1, 2018
• Study Start: September 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 30, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Locations

SE (1)