Assessment of the Clinical Efficacy of the Heart Spectrum Blood Pressure Monitor for Diagnosis of Atrial Fibrillation

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Heart Spectrum Blood Pressure Monitor

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 12-lead ECG	Device: Heart Spectrum Blood Pressure Monitor; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	monitoring for about 60 seconds per test

Collaborators and Investigators

• Sponsor: Ostar Meditech Corp

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2016
• Primary Completion (Actual): June 23, 2016
• Study Completion (Actual): December 7, 2016

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Heart Spectrum Blood Pressure MonitorHeart Spectrum
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: TMU JIRB No.: N201510061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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