Home Monitoring for Atrial Fibrillation Using a Microlife Blood Pressure Monitor

Overview

This study assess the accuracy of a blood pressure monitor designed to detect atrial fibrillation. Subjects use the blood pressure monitor on a daily basis for 30 days and compare the readings to an ECG done at the same time.

Full Title of Study: “Home Monitoring for Atrial Fibrillation Using a Microlife Blood Pressure Monitor: Trial of Regular vs Irregualr Pulse for the Prevention of Stroke (TRIPPS 2.0)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2009

Interventions

  • Device: Microlife blood pressure monitor with AF detection (Microlife AFIB MLU3MQ1)
    • Monitoring heart rhythm daily for 30 days using the blood pressure monitor and the ECG recorder.

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity and specificity of the blood pressure monitor used for detecting atrial fibrillation compared to the electrocardiogram.
    • Time Frame: After final subject data is available.

Secondary Measures

  • Assess subjects understanding of the use of the device for atrial fibrillation.
    • Time Frame: After final subject data is available.

Participating in This Clinical Trial

Inclusion Criteria

any of the following

  • age 65 or older – hypertension – diabetes mellitus – congestive heart failure – previous stroke Exclusion Criteria:

  • permanent pacemaker – impalantable defibrillator

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Microlife
  • Provider of Information About this Clinical Study
    • Joseph Wiesel, MD, Microlife
  • Overall Official(s)
    • Joseph Wiesel, MD, Principal Investigator,

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