We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection

This study has been terminated.
(the study design was not good. the use of garment and telemetry device simultaneously impact the ECG recording quality.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01913561
First Posted: August 1, 2013
Last Update Posted: August 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
HealthWatch Ltd.
  Purpose

The Master Caution Garment is embedded with 10/13 textile dry electrodes that enable 12/15-lead ECG.

The electrodes are dry, textile ECG electrodes. The garment is designed to position the electrodes in the appropriate anatomical locations, without any special guidance. The dry electrodes are made from unique yarns with silver embedded into the garment using a proprietary technique developed by HealthWatch (HW)that obviates the need for skin preparation or the application of fluids. The garment can be connected to any standard ECG device available in the hospitals.

The purpose of this study is to evaluate the safety and effectiveness of the Master Caution Garment for continuous monitoring of ECG signal compared to standard gel electrodes.

The following endpoints will be evaluated in subjects participating in the study:

Primary:

Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes using standard ECG devices.

Secondary:

Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes when event is detected by the ECG devices.


Condition Intervention
Arrhythmia Device: Master Caution Garment Device: ECG gel electrodes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection Compared To Standard Gel-Electrode-Based ECG

Further study details as provided by HealthWatch Ltd.:

Primary Outcome Measures:
  • From the ECG record collect the Heart Rate HR. [ Time Frame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. ]
  • From the ECG record collect the P Wave width (sec.) and the amplitude (mV). [ Time Frame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. ]
  • From the ECG record collect the QRS Complex width (sec.) and the amplitude (mV). [ Time Frame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. ]
  • From the ECG record collect the T Wave width (sec.) and the amplitude (mV). [ Time Frame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. ]
  • From the ECG record collect the RR Interval width (sec.). [ Time Frame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. ]
  • From the ECG record collect the PR Interval width (sec.). [ Time Frame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. ]
  • From the ECG record collect the QT Interval width (sec.). [ Time Frame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. ]

Enrollment: 16
Study Start Date: September 2013
Estimated Study Completion Date: August 2017
Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Master Caution Garment

each patient will be connected simultaneously with two devices:

  • ECG gel electrodes
  • Master Caution Garment textile electrodes The two devices will be connected to hospital ECG telemetry.
Device: Master Caution Garment

Master Caution Garment is embedded with 10/13 textile dry electrodes that enable 12/15-lead ECG.

The electrodes are dry, textile ECG electrodes.

Other Name: MCG
Device: ECG gel electrodes
Standard gel electrodes that are been in use in hospital for ECG monitoring.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age>18 years.
  • Suspected for arrhythmia or have evidence of arrhythmia disorder.
  • Needs continuous, in-hospital ECG monitoring.
  • Ability to give informed consent.

Exclusion Criteria:

  • Patients with known allergy to silver.
  • Patients with recent trauma to chest wall.
  • Pregnant or lactating woman.
  • Patients with chest deformity precluding placement of the garment.
  • Patients participating in another ongoing trial.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913561


Locations
Israel
Rambam medical center
Haifa, Israel, 9602
Sponsors and Collaborators
HealthWatch Ltd.
Investigators
Principal Investigator: Robert Zukerman, Dr. Rambam medical center Haifa, Israel
  More Information

Responsible Party: HealthWatch Ltd.
ClinicalTrials.gov Identifier: NCT01913561     History of Changes
Other Study ID Numbers: HWG001
First Submitted: July 24, 2013
First Posted: August 1, 2013
Last Update Posted: August 23, 2017
Last Verified: September 2016

Keywords provided by HealthWatch Ltd.:
Electrocardiogram
gel electrodes
textile electrodes


To Top