MedTrace Logo

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

NCT03095131 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2017-03-29

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Ostar Meditech Corp

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-22
Primary Completion
2016-06-23
Completion
2016-12-07
FDA Device
Yes

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03095131 on ClinicalTrials.gov