Atrial FibrillationPhase 4NCT05089435
An Open-label Study of EZYPRO® in Atrial Fibrillation Detection on ESUS Patients
A Phase 4 study testing EZYPRO® ECG Recorder in people with Atrial Fibrillation and Embolic Stroke of Undetermined Source, run by Sigknow Biomedical Co., Ltd. at 1 site in Taiwan.
Trial summary
The aim of the study is to evaluate the effectiveness and safety of the 14-day continuous ECG patch monitor (EZYPRO®) compared with a 24-hour Holter monitor in the detection of atrial fibrillation (AF) among ESUS patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Atrial Fibrillation, Embolic Stroke of Undetermined Source
- What is being tested?
- EZYPRO® ECG Recorder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Mar 2022to Dec 2023
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are male or female, aged ≥ 50 years.
- Patients must be able to understand and sign the informed consent documents within 10 days of ischemic stroke diagnosis and aware of the investigational nature of the study.
- Patients must be willing to comply with protocol stated requirements, instructions, and restrictions during the study.
- Patients who have stable vital signs for at least 24 hours, defined as normal respiration, afebrile, and systolic blood pressure ≤ 220 mmHg.
- Patients who are diagnosed with acute ischemic stroke and undergo a diagnostic workup using brain magnetic resonance imaging (MRI), brain magnetic resonance angiography (MRA), 12-lead ECG, carotid duplex ultrasound, with or without transcranial color-coded duplex sonography (TCCS), and cardiac echo (transthoracic echocardiography [TTE]) to meet the concept of "nearly embolic stroke of undetermined source (ESUS)" as defined by the following criteria:
- Acute cerebral infarct, as identified by hyperintensity in diffusion-weighted imaging (DWI) of MRI and hypointensity for apparent diffusion coefficient (ADC) b. DWI of MRI showing non-lacunar stroke, defined as a subcortical infarct ≤ 2.0 cm in largest dimension within the territory of the small penetrating cerebral arteries c. Absence of ≥ 50% stenosis of the intracranial or extracranial artery associated with the infarcted lesion as confirmed by brain MRA, carotid duplex, and/or TCCS d. No medical history of AF e. No major-risk cardioembolic sources including AF, atrial flutter, intracardiac thrombus, prosthetic cardiac valve, atrial myxoma or other cardiac tumors, mitral stenosis, recent (< 4 weeks) myocardial infarction, left ventricular ejection fraction < 30%, valvular vegetations or infective endocarditis f. No other specific cause of stroke identified (e.g., arteritis, dissection, migraine, and cancer-related hypercoagulability etc.) g. Not ischemic stroke located at specific regions or severe hemorrhagic infarct identified by brain MRI, including: (i.) Large pontine infarct, which more likely belongs to branch artery disease (BAD) (ii.) Anterior choroidal artery infarct (iii.) Internal border zone infarct, represented with rosary-like pattern of lesions between the territories of lenticulostriate artery and superficial branch of middle cerebral artery (MCA) (iv.) Severe hemorrhagic transformation of acute ischemic stroke, which may impede the usage of antiplatelet agents or anticoagulant within 14 days post-stroke per the investigator's judgment
Who cannot join
- Patients with the following skin related issues that could put patients at risk, interfere with study evaluations, or prevent meeting the requirements of the study:
- Intolerable, severe skin allergies to the 24-hour Holter monitor or 14-day EZYPRO® or history of severe skin allergies to medical adhesive bandages
- Any injury, eczema, dermatitis, chromatosis, or abnormality at the skin site where devices are applied
- Hyperhidrosis
- Patients who have contraindication to either of the antiplatelet agents which might be used in this study (i.e. aspirin and/or clopidogrel) or to all types of non-vitamin K antagonist oral anticoagulant (NOAC) (due to allergy, mechanical valve replacement, renal insufficient with creatinine clearance [CCr] < 15 ml/min, moderate to severe mitral stenosis, etc.).
- Patients who are evaluated as Modified Rankin Scale > 4.
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- Mental/physical/social condition (including dementia) which could preclude performing efficacy or safety assessments.
- Patients with following condition or diseases:
- Medical history of major bleeding impeding usage of antiplatelet agents or NOAC
- Medical history of brain or other clinically significant neurological/cardiovascular disorders or injuries other than ischemic stroke in the opinion of the investigator
- Clinically significant or unstable gastrointestinal, renal, hepatic, endocrine, pulmonary, or cardiovascular disease, including not well controlled hypertension, chronic obstructive pulmonary disease, and diabetes that would hinder or interfere participation to the study in the opinion of the investigator
- Patients who need to receive anticoagulation therapy prior to the screening visit.
- Patients who meet following conditions:
- Patients who are scheduled to receive surgery that may have to stop anticoagulation or antiplatelet therapy during the study period
- Patients who are scheduled to receive neurological or cardiovascular intervention during the trial period
- Patients who are unable to undergo brain MRI for any reason.
- Currently participating in another trial or who participated in a previous clinical trial and received any treatment which may interfere the study data within 2 weeks prior to the screening visit.
- Patients who need to receive long-term (> 21 days) dual antiplatelet therapy or anticoagulant therapy prior to AF detection after study enrollment.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Jiann-Shing Jeng, PhD
Jiann-Shing Jeng, PhD
About this study
Official title: An Open-label Study to Evaluate the Effectiveness and Safety of EZYPRO® in Atrial Fibrillation Detection in Nearly Embolic Stroke of Undetermined Source (ESUS) Patient
The aim of the study is to evaluate the effectiveness and safety of the 14-day continuous ECG patch monitor (EZYPRO®) compared with a 24-hour Holter monitor in the detection of atrial fibrillation (AF) among ESUS patients.
- Being tested
- EZYPRO® ECG Recorder
- Keywords
- ESUS, stoke, arrhythmia, atrial fibrillation, ECG patch, continuous ECG monitoring
- 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® ECG RecorderDevice
EZYPRO is an ECG monitoring patch designed to enhance the arrhythmia detection rate by applying 14 days in a home setting environment.
| Study group | Role | What they receive |
|---|---|---|
| 14-day EZYPRO and 24-hr Holter | Other | Patients wear simultaneously 14- day continuous ECG moniter (EZYPRO) and 24-hr Holter monitor. Receives: Device: EZYPRO® ECG Recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Afib detected by 24-hour Holter
Day 1 of the trial, patients will wear simultaneously 24-hour Holter and the trial device, EZYPRO 14-day monitoring patch. After at least 20 hours of Holter, it will be removed and the ECG data will be collected and analyzed for arrhythmia, especially atrial fibrillation. If AF is detected by Holter, patients will be prescribed NOAC; if no AF is detected, patients will be prescribed antiplatelet agents instead.
Measured: 24 hours
Afib detected by 14-day EZYPRO
Day 1 of the trial, patients will wear simultaneously a 24-hour Holter, and the trial device, EZYPRO 14-day monitoring patch. 24-hour Holter will be removed first after at least wearing it for 20 hours with the continuant of EZYPRO. Patients have to wear EZYPRO for up to 14 days (the minimum wear time is 10 days). After the patch removal, the ECG data will be analyzed by the sponsor ECG analysis team and provide an ECG report to investigators. Arrhythmias, especially AF, will be presented in the report for further treatment. If AF is detected by EZYPRO and Holter, patients will be prescribed NOAC; if no AF is detected by either one, patients will be prescribed antiplatelet agents instead.
Measured: 14 days
Secondary outcomes (1)
Skin irritation by EZYPRO patch
Before wearing 24-hour Holter and EZYPRO, patients' skin condition will be assessed by trial investigators based on Dermal Response Score, FDA-2018-D-3546, on a scale of 0 to 7. Before and after wearing EZYPRO, the skin condition will be assessed at each visit. At each follow-up visit, the skin condition will be assessed as well. The aim of this evaluation is to observe the safety of EZYPRO and confirm if it will help enhance patient compliance.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start28 Mar 2022
- Primary completionMar 2023 (estimated)
- Study completionDec 2023 (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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients should wear simultaneously the trial device EZYPRO and a 24-hr Holter monitor.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sigknow Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Ming Lien, PhD, Principal investigator, Shin Kong Wu Ho-Su Memorial HospitalLi Kai Tsai, PhD, Study director, National Taiwan University Hospital Hsin-Chu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089435
- Sponsor's protocol ID
- SIGEZYH20180823
- Status last verified
- May 2022
- First submitted
- 3 Oct 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Effectiveness and Safety of EZYPRO® in Atrial Fibrillation Detection in Nearly Embolic Stroke of Undetermined Source (ESUS) Patient
- ClinicalTrials.gov ID
- NCT05089435
- Acronym / sponsor ID
- SIGEZYH20180823
- Keywords
- ESUS, stoke, arrhythmia, atrial fibrillation, ECG patch, continuous ECG monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sigknow Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Oct 2021 (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.
The aim of the study is to evaluate the effectiveness and safety of the 14-day continuous ECG patch monitor (EZYPRO®) compared with a 24-hour Holter monitor in the detection of atrial fibrillation (AF) among ESUS patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients should wear simultaneously the trial device EZYPRO and a 24-hr Holter monitor.
| Arm | Type | Receives |
|---|---|---|
| 14-day EZYPRO and 24-hr Holter | Other | Device: EZYPRO® ECG RecorderPatients wear simultaneously 14- day continuous ECG moniter (EZYPRO) and 24-hr Holter monitor. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients are male or female, aged ≥ 50 years.
- Patients must be able to understand and sign the informed consent documents within 10 days of ischemic stroke diagnosis and aware of the investigational nature of the study.
- Patients must be willing to comply with protocol stated requirements, instructions, and restrictions during the study.
- Patients who have stable vital signs for at least 24 hours, defined as normal respiration, afebrile, and systolic blood pressure ≤ 220 mmHg.
- Patients who are diagnosed with acute ischemic stroke and undergo a diagnostic workup using brain magnetic resonance imaging (MRI), brain magnetic resonance angiography (MRA), 12-lead ECG, carotid duplex ultrasound, with or without transcranial color-coded duplex sonography (TCCS), and cardiac echo (transthoracic echocardiography [TTE]) to meet the concept of "nearly embolic stroke of undetermined source (ESUS)" as defined by the following criteria:
Key exclusion criteria (18 listed)
- Patients with the following skin related issues that could put patients at risk, interfere with study evaluations, or prevent meeting the requirements of the study:
- Patients who have contraindication to either of the antiplatelet agents which might be used in this study (i.e. aspirin and/or clopidogrel) or to all types of non-vitamin K antagonist oral anticoagulant (NOAC) (due to allergy, mechanical valve replacement, renal insufficient with creatinine clearance [CCr] < 15 ml/min, moderate to severe mitral stenosis, etc.).
- Patients who are evaluated as Modified Rankin Scale > 4.
- Mental/physical/social condition (including dementia) which could preclude performing efficacy or safety assessments.
- Patients with following condition or diseases:
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® ECG RecorderEZYPRO is an ECG monitoring patch designed to enhance the arrhythmia detection rate by applying 14 days in a home setting environment. | Device | 14-day EZYPRO and 24-hr Holter |
Primary outcome
Afib detected by 24-hour Holter
Time frame: 24 hours
Day 1 of the trial, patients will wear simultaneously 24-hour Holter and the trial device, EZYPRO 14-day monitoring patch. After at least 20 hours of Holter, it will be removed and the ECG data will be collected and analyzed for arrhythmia, especially atrial fibrillation. If AF is detected by Holter, patients will be prescribed NOAC; if no AF is detected, patients will be prescribed antiplatelet agents instead.
Afib detected by 14-day EZYPRO
Time frame: 14 days
Day 1 of the trial, patients will wear simultaneously a 24-hour Holter, and the trial device, EZYPRO 14-day monitoring patch. 24-hour Holter will be removed first after at least wearing it for 20 hours with the continuant of EZYPRO. Patients have to wear EZYPRO for up to 14 days (the minimum wear time is 10 days). After the patch removal, the ECG data will be analyzed by the sponsor ECG analysis team and provide an ECG report to investigators. Arrhythmias, especially AF, will be presented in the report for further treatment. If AF is detected by EZYPRO and Holter, patients will be prescribed NOAC; if no AF is detected by either one, patients will be prescribed antiplatelet agents instead.
1 secondary outcome
Skin irritation by EZYPRO patch
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Atrial Fibrillation (AF)
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.
Li Ming Lien, PhD principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
Li Kai Tsai, PhD study director
National Taiwan University Hospital Hsin-Chu Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EZYPRO® ECG Recorder in people with Atrial Fibrillation and Embolic Stroke of Undetermined Source, run by Sigknow Biomedical Co., Ltd. at 1 site 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 6 inclusion and 18 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 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nancy Lu (+886227612577 ext. 134, nancy.lu@sigknow.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Afib detected by 24-hour Holter (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 10 May 2022.