Arrhythmia Clinical Trial
Official title:
The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection Compared To Standard Gel-Electrode-Based ECG
NCT number | NCT01913561 |
Other study ID # | HWG001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2013 |
Est. completion date | August 31, 2017 |
Verified date | August 2018 |
Source | HealthWatch Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | August 31, 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam medical center | Haifa |
Lead Sponsor | Collaborator |
---|---|
HealthWatch Ltd. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | From the ECG record collect the Heart Rate HR. | 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. | ||
Primary | From the ECG record collect the P Wave width (sec.) and the amplitude (mV). | 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. | ||
Primary | From the ECG record collect the QRS Complex width (sec.) and the amplitude (mV). | 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. | ||
Primary | From the ECG record collect the T Wave width (sec.) and the amplitude (mV). | 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. | ||
Primary | From the ECG record collect the RR Interval width (sec.). | 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. | ||
Primary | From the ECG record collect the PR Interval width (sec.). | 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. | ||
Primary | From the ECG record collect the QT Interval width (sec.). | 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. |
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