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Clinical Trials/NCT03001206
NCT03001206CompletedNot Applicable

The Use of Master Caution System for Continuous Monitoring and Detection of Dysrhythmia and Ischemia

HealthWatch Ltd.1 site in 1 country84 target enrollmentStarted: January 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
84
Locations
1
Primary Endpoint
Measuring 12 leads ECG information of patients at the ICCU in continuous monitoring using Master Caution System (MCS) will give more cardiac information comparing to regular hospital 2-3 leads telemetry.

Study Overview

Brief Summary

The purpose of this study is to evaluate the effectiveness and usability of the Master Caution System for 12 leads continuous monitoring of ECG signal in the ICCU.

The purpose of the study is to evaluate the effectiveness and usability of using Master Caution 12 leads Garment for stress test.

The purpose of the study is to reassess the adequate size of the Master Caution Garment.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age>18 years.
  • Diagnosed or have evidence of ACS, or referred for stress imaging due to suspected ischemia with STT changes.
  • Needs continuous/routine ECG monitoring.
  • Ability to give informed consent.
  • Cooperative person

Exclusion Criteria

  • Patients with known allergy to silver.
  • Patients with dermal disease or recent trauma to the chest wall.
  • Pregnant or lactating woman.
  • Patients with chest deformity precluding placement of the garment.
  • Patients suffering from tremor.
  • Patients participating in another ongoing trial.

Outcomes

Primary Outcomes

Measuring 12 leads ECG information of patients at the ICCU in continuous monitoring using Master Caution System (MCS) will give more cardiac information comparing to regular hospital 2-3 leads telemetry.

Time Frame: 48 hours

Measuring 12 leads ECG information of patients at the stress test using Master Caution System (MCS) comparing to the standard of care stress test ECG device and Electrodes.

Time Frame: 1-2 hours

Secondary Outcomes

  • Master Caution System (MCS) cardiac telemetry system will measure and provide sufficient ECG information for adequate detection and interpretation of ST-T wave changes and dysrhythmic events.(during the use of the system)

Investigators

Sponsor
HealthWatch Ltd.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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