Atrial FibrillationNCT03095131
Assessment of the Clinical Efficacy of the Heart Spectrum Blood Pressure Monitor for Diagnosis of Atrial Fibrillation
A study testing Heart Spectrum Blood Pressure Monitor in people with Atrial Fibrillation, run by Ostar Meditech Corp.
Trial summary
Question: Is 12-lead electrocardiography (ECG) the most accurate and convenient diagnostic method for atrial fibrillation (AF)? Findings: The Heart Spectrum Blood Pressure Monitor can be used at home, and is capable of determining the occurrence of AF. Three measurement methods were used in this study. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Heart Spectrum Blood Pressure Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2016to 7 Dec 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects older than 20 years of age who had been diagnosed with AF using 12-lead ECG, or were healthy (without AF) were included.
Who cannot join
- Subjects who had been exposed to high frequency surgical equipment during testing, those with cardiac pacemakers or implantable defibrillators, and pregnant women were excluded.
About this study
Official title: Assessment of the Clinical Efficacy of the Heart Spectrum Blood Pressure Monitor for Diagnosis of Atrial Fibrillation: An Unblinded Clinical Trial
Question: Is 12-lead electrocardiography (ECG) the most accurate and convenient diagnostic method for atrial fibrillation (AF)? Findings: The Heart Spectrum Blood Pressure Monitor can be used at home, and is capable of determining the occurrence of AF. Three measurement methods were used in this study. The sensitivity, specificity, PPV, and NPV of the methods used are between 90% and 100%, and the Heart Spectrum Blood Pressure Monitor can be effectively applied to AF detection.
Meaning: The Heart Spectrum Blood Pressure Monitor can be used at home and can replace the need for an in-office ECG, thereby accomplishing meaningful telecare.
Read the detailed description
Importance: Atrial fibrillation (AF) is the most common arrhythmia. The most common diagnostic method, 12-lead ECG, can record episodes of arrhythmia from which the type and severity can be determined. The Heart Spectrum Blood Pressure Monitor (P2, OSTAR Meditech Corp.) is used to measure cardiovascular pressure change, with fast Fourier transform (FFT) analysis, to obtain the heart rate frequency variability and accurate blood pressure data.
Objective: To compare the diagnostic efficacy of the Heart Spectrum Blood Pressure Monitor with a 12-lead ECG in patients with AF. Three measurement methods were used in this study: blood pressure, mean arterial pressure (MAP) which is calculated from individual blood pressure as constant pressure, and a constant pressure 60 mmHg, in order to analyze the heart index and compare it with simultaneous 12-lead ECG.
Design: The physician used a 12-lead ECG and the Heart Spectrum Blood Pressure Monitor simultaneously. The Heart Spectrum Blood Pressure Monitor used an FFT analysis for the diagnosis of AF; the findings were compared with the readings from the 12-lead ECG.
Setting: This unblinded clinical trial was conducted at the Emergency Room of Taipei Medical University Hospital.
Participants: Twenty-nine subjects with AF and 33 without AF, aged 25 to 97 years (mean: 63.5 years), were included.
Intervention(s) for clinical trials Subjects who had been exposed to high frequency surgical equipment during testing, those with cardiac pacemakers or implantable defibrillators, and pregnant women were excluded.
Trial Registration: TMU JIRB No.: N201510061
- Conditions
- Atrial Fibrillation
- Being tested
- Heart Spectrum Blood Pressure Monitor
- Keywords
- Heart Spectrum Blood Pressure MonitorHeart Spectrum
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Spectrum Blood Pressure MonitorDevice
The Heart Spectrum Blood Pressure Monitor provides a convenient and effective filtering application compared with traditional methods that require a visit to a physician for a 12-lead ECG.
| Study group | Role | What they receive |
|---|---|---|
| 12-lead ECG | Experimental | Not described Receives: Device: Heart Spectrum Blood Pressure Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Heart Spectrum Blood Pressure Monitor used an FFT analysis for the diagnosis of AF; the findings were compared with the readings from the 12-lead ECG.
In the emergency room, when medical staff found patients with AF, they informed the research physicians to study the case. The Heart Spectrum Blood Pressure Monitor was compared with 12-lead ECG (ELI 250) after written informed consent was obtained from the patient. The results were interpreted by the emergency physician. Finally, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were analyzed to evaluate the clinical efficacy.
Measured: monitoring for about 60 seconds per test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start22 Feb 2016
- Primary completion23 Jun 2016
- Study completion7 Dec 2016
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostar Meditech Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095131
- Sponsor's protocol ID
- TMU JIRB No.: N201510061
- Status last verified
- Mar 2017
- First submitted
- 17 Mar 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Clinical Efficacy of the Heart Spectrum Blood Pressure Monitor for Diagnosis of Atrial Fibrillation: An Unblinded Clinical Trial
- ClinicalTrials.gov ID
- NCT03095131
- Acronym / sponsor ID
- TMU JIRB No.: N201510061
- Conditions
- Atrial Fibrillation
- Keywords
- Heart Spectrum Blood Pressure MonitorHeart Spectrum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ostar Meditech CorpIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2016 (actual)
- Primary completion
- 23 Jun 2016 (actual)
- Study completion
- 7 Dec 2016 (actual)
- First posted
- 29 Mar 2017 (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.
Question: Is 12-lead electrocardiography (ECG) the most accurate and convenient diagnostic method for atrial fibrillation (AF)? Findings: The Heart Spectrum Blood Pressure Monitor can be used at home, and is capable of determining the occurrence of AF. Three measurement methods were used in this study. The sensitivity, specificity, PPV, and NPV of the methods used are between 90% and 100%, and the Heart Spectrum Blood Pressure Monitor can be effectively applied to AF detection.
Meaning: The Heart Spectrum Blood Pressure Monitor can be used at home and can replace the need for an in-office ECG, thereby accomplishing meaningful telecare.
Detailed description
Importance: Atrial fibrillation (AF) is the most common arrhythmia. The most common diagnostic method, 12-lead ECG, can record episodes of arrhythmia from which the type and severity can be determined. The Heart Spectrum Blood Pressure Monitor (P2, OSTAR Meditech Corp.) is used to measure cardiovascular pressure change, with fast Fourier transform (FFT) analysis, to obtain the heart rate frequency variability and accurate blood pressure data.
Objective: To compare the diagnostic efficacy of the Heart Spectrum Blood Pressure Monitor with a 12-lead ECG in patients with AF. Three measurement methods were used in this study: blood pressure, mean arterial pressure (MAP) which is calculated from individual blood pressure as constant pressure, and a constant pressure 60 mmHg, in order to analyze the heart index and compare it with simultaneous 12-lead ECG.
Design: The physician used a 12-lead ECG and the Heart Spectrum Blood Pressure Monitor simultaneously. The Heart Spectrum Blood Pressure Monitor used an FFT analysis for the diagnosis of AF; the findings were compared with the readings from the 12-lead ECG.
Setting: This unblinded clinical trial was conducted at the Emergency Room of Taipei Medical University Hospital.
Participants: Twenty-nine subjects with AF and 33 without AF, aged 25 to 97 years (mean: 63.5 years), were included.
Intervention(s) for clinical trials Subjects who had been exposed to high frequency surgical equipment during testing, those with cardiac pacemakers or implantable defibrillators, and pregnant women were excluded.
Trial Registration: TMU JIRB No.: N201510061
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 12-lead ECG | Experimental | Device: Heart Spectrum Blood Pressure Monitor |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects older than 20 years of age who had been diagnosed with AF using 12-lead ECG, or were healthy (without AF) were included.
Key exclusion criteria (1 listed)
- Subjects who had been exposed to high frequency surgical equipment during testing, those with cardiac pacemakers or implantable defibrillators, and pregnant women were excluded.
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 |
|---|---|---|
| Heart Spectrum Blood Pressure MonitorThe Heart Spectrum Blood Pressure Monitor provides a convenient and effective filtering application compared with traditional methods that require a visit to a physician for a 12-lead ECG. | Device | 12-lead ECG |
Primary outcome
The Heart Spectrum Blood Pressure Monitor used an FFT analysis for the diagnosis of AF; the findings were compared with the readings from the 12-lead ECG.
Time frame: monitoring for about 60 seconds per test
In the emergency room, when medical staff found patients with AF, they informed the research physicians to study the case. The Heart Spectrum Blood Pressure Monitor was compared with 12-lead ECG (ELI 250) after written informed consent was obtained from the patient. The results were interpreted by the emergency physician. Finally, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were analyzed to evaluate the clinical efficacy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Spectrum Blood Pressure Monitor in people with Atrial Fibrillation, run by Ostar Meditech Corp.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Heart Spectrum Blood Pressure Monitor used an FFT analysis for the diagnosis of AF; the findings were compared with the readings from the 12-lead ECG. (time frame: monitoring for about 60 seconds per test). 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 29 Mar 2017.