Atrial FibrillationNCT03602742
Comparison of 24-hour Holter Monitoring Versus 14-day Continuous ECG Patch Monitoring EZYPRO
A study testing EZYPRO® in people with Atrial Fibrillation and Arrhythmias, Cardiac, run by Sigknow Biomedical Co., Ltd. at 2 sites in Taiwan.
Trial summary
This is an open-label study to investigate the functional features of prolonged monitoring by 14-day EZYPRO® to improve the medical care and/or diagnosis for the patient with arrhythmia. Patients will be enrolled by outpatient basis from two clinical study sites. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation, Arrhythmias, Cardiac
- What is being tested?
- EZYPRO®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesTaiwan
- Study dates
- 16 Mar 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed written informed consent before enrollment into the study
- Are able to communicate with the investigators
- With suspected arrhythmia related signs and symptoms, judged by the investigators
- Patients intend to wear ECG moniotrs
- Males and females, 20 years of age or older
Who cannot join
- Patients with skin allergies or injury, judged by investigators
- Patients with specific arrhythmia or specific treatments, interfere with study evaluations, judged by investigators
- Pregnant women
- Currently participating in another trial or who participated in a previous clinical trial
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Taipei Veterans General Hospital, Taiwan
Taipei
Ethan Kao, +886 2 2761 2577, contact@sigknow.com.tw
- Recruiting
Chang Gung Medical Foundation, Linkou
Taoyuan
Ethan Kao, +886 2 2761 2577 ext. 8119, contact@sigknow.com.tw
About this study
This is an open-label study to investigate the functional features of prolonged monitoring by 14-day EZYPRO® to improve the medical care and/or diagnosis for the patient with arrhythmia. Patients will be enrolled by outpatient basis from two clinical study sites. Enrolled patients will wear a traditional 24-hour Holter monitor and an 14-day EZYPRO® which can provide monitoring data for up to 14 days. This study will allow a direct comparison between two devices.
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac
- Being tested
- EZYPRO®
- Keywords
- Atrial Fibrillation, Arrhythmias, Cardiac, EZYPRO ECG Recorder, ECG monitor, Long term ECG monitor, 14-day ECG monitor
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EZYPRO®Device
Also called 24-hour Holter
Wear two devices including 24-hour Holter and 14-day continuous EZYPRO® to evaluate the performance
| Study group | Role | What they receive |
|---|---|---|
| 24-hour Holter and 14-day EZYPRO® | Other | This is an open-label study to investigate the functional features of prolonged monitoring by 14-day EZYPRO® to improve the medical care and/or diagnosis for the patient with arrhythmia. One arm included. Receives: Device: EZYPRO® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the detection difference of any type of arrhythmia between 14-day continuous ECG patch and 24-hour Holter monitor device among patients with suspected cardiac arrhythmia events over total wearing time
The arrhythmia events of 14-day continuous ECG patch monitor (investigational device) and 24-hour Holter monitor will be analyzed by the qualified ECG technicians and determined by physician investigators at the study sites. Arrhythmia events are defined as detection of any 1 of 6 arrhythmias, including:
- Supraventricular tachycardia (>4 beats, not including atrial fibrillation or flutter)
- Atrial fibrillation/flutter (>4 beats)
- Pause >3 seconds
- Atrioventricular block (Second-degree, 2:1 or third-degree atrioventricular block, need an advanced determination by the investigators)
- Ventricular tachycardia (>4 beats)
- Polymorphic ventricular tachycardia/ventricular fibrillation In the end, all the detection will be confirmed by the investigators.
McNemar's tests will be used to compare the matched pairs of proportion data.
Measured: Up to14 days
Secondary outcomes (1)
The wearing time of 14-day continuous ECG patch (Study Compliance)
The wearing time will be recorded as the day of 14-day continuous ECG patch removal after stating monitoring. Kaplan-Meier method will be reported for total wearing time. The mean value along with two-sided 95% confidence intervals will be report as well.
Measured: Up to14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start16 Mar 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sigknow Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ming-Shien Wen, Principal investigator, Chang Gung Medical Foundation, LinkouShih-Lin Chang, Principal investigator, Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602742
- Sponsor's protocol ID
- SIGEZYZ20170828
- Status last verified
- Jul 2018
- First submitted
- 24 May 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 24-hour Holter Monitoring Versus 14-day Continuous ECG Patch Monitoring EZYPRO
- ClinicalTrials.gov ID
- NCT03602742
- Acronym / sponsor ID
- SIGEZYZ20170828
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac
- Keywords
- Atrial Fibrillation, Arrhythmias, Cardiac, EZYPRO ECG Recorder, ECG monitor, Long term ECG monitor, 14-day ECG monitor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sigknow Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label study to investigate the functional features of prolonged monitoring by 14-day EZYPRO® to improve the medical care and/or diagnosis for the patient with arrhythmia. Patients will be enrolled by outpatient basis from two clinical study sites. Enrolled patients will wear a traditional 24-hour Holter monitor and an 14-day EZYPRO® which can provide monitoring data for up to 14 days. This study will allow a direct comparison between two devices.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 24-hour Holter and 14-day EZYPRO® | Other | Device: EZYPRO®This is an open-label study to investigate the functional features of prolonged monitoring by 14-day EZYPRO® to improve the medical care and/or diagnosis for the patient with arrhythmia. One arm included. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of signed written informed consent before enrollment into the study
- Are able to communicate with the investigators
- With suspected arrhythmia related signs and symptoms, judged by the investigators
- Patients intend to wear ECG moniotrs
- Males and females, 20 years of age or older
Key exclusion criteria (4 listed)
- Patients with skin allergies or injury, judged by investigators
- Patients with specific arrhythmia or specific treatments, interfere with study evaluations, judged by investigators
- Pregnant women
- Currently participating in another trial or who participated in a previous clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EZYPRO®Also: 24-hour HolterWear two devices including 24-hour Holter and 14-day continuous EZYPRO® to evaluate the performance | Device | 24-hour Holter and 14-day EZYPRO® |
Primary outcome
Compare the detection difference of any type of arrhythmia between 14-day continuous ECG patch and 24-hour Holter monitor device among patients with suspected cardiac arrhythmia events over total wearing time
Time frame: Up to14 days
The arrhythmia events of 14-day continuous ECG patch monitor (investigational device) and 24-hour Holter monitor will be analyzed by the qualified ECG technicians and determined by physician investigators at the study sites. Arrhythmia events are defined as detection of any 1 of 6 arrhythmias, including: * Supraventricular tachycardia (>4 beats, not including atrial fibrillation or flutter) * Atrial fibrillation/flutter (>4 beats) * Pause >3 seconds * Atrioventricular block (Second-degree, 2:1 or third-degree atrioventricular block, need an advanced determination by the investigators) * Ventricular tachycardia (>4 beats) * Polymorphic ventricular tachycardia/ventricular fibrillation In the end, all the detection will be confirmed by the investigators. McNemar's tests will be used to compare the matched pairs of proportion data.
1 secondary outcome
The wearing time of 14-day continuous ECG patch (Study Compliance)
Time frame: Up to14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
Related trials for Atrial Fibrillation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Shien Wen principal investigator
Chang Gung Medical Foundation, Linkou
Shih-Lin Chang principal investigator
Veterans General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EZYPRO® in people with Atrial Fibrillation and Arrhythmias, Cardiac, run by Sigknow Biomedical Co., Ltd. at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sigknow Biomedical Co., LTD (+886 2 27612577 ext. 102, ethan.kao@sigknow.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the detection difference of any type of arrhythmia between 14-day continuous ECG patch and 24-hour Holter monitor device among patients with suspected cardiac arrhythmia events over total wearing time (time frame: Up to14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2018.