Assessment of the Clinical Efficacy of the Heart Spectrum Blood Pressure Monitor for Diagnosis of Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Heart Spectrum Blood Pressure Monitor
Sponsored by
About this trial
This is an interventional device feasibility trial for Atrial Fibrillation focused on measuring Heart Spectrum Blood Pressure MonitorHeart Spectrum
Eligibility Criteria
Inclusion Criteria:
- Subjects older than 20 years of age who had been diagnosed with AF using 12-lead ECG, or were healthy (without AF) were included.
Exclusion Criteria:
- Subjects who had been exposed to high frequency surgical equipment during testing, those with cardiac pacemakers or implantable defibrillators, and pregnant women were excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
12-lead ECG
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03095131
Brief Title
Assessment of the Clinical Efficacy of the Heart Spectrum Blood Pressure Monitor for Diagnosis of Atrial Fibrillation
Official Title
Assessment of the Clinical Efficacy of the Heart Spectrum Blood Pressure Monitor for Diagnosis of Atrial Fibrillation: An Unblinded Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 22, 2016 (Actual)
Primary Completion Date
June 23, 2016 (Actual)
Study Completion Date
December 7, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ostar Meditech Corp
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Heart Spectrum Blood Pressure MonitorHeart Spectrum
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
12-lead ECG
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Heart Spectrum Blood Pressure Monitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
monitoring for about 60 seconds per test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects older than 20 years of age who had been diagnosed with AF using 12-lead ECG, or were healthy (without AF) were included.
Exclusion Criteria:
Subjects who had been exposed to high frequency surgical equipment during testing, those with cardiac pacemakers or implantable defibrillators, and pregnant women were excluded.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of the Clinical Efficacy of the Heart Spectrum Blood Pressure Monitor for Diagnosis of Atrial Fibrillation
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