Device-detected Paroxysmal Atrial Fibrillation

April 17, 2019 updated by: University of Birmingham

Validation of the Modified Microlife Blood Pressure Monitor in Patients With Paroxysmal Atrial Fibrillation

This study will use an automated blood pressure monitor (Microlife WatchBP03) with an inbuilt algorithm to detect atrial fibrillation (an irregular heart rhythm) in patients with an implanted pacemaker who have previously documented paroxysmal (intermittent) atrial fibrillation. This study will compare the Microlife device detected atrial fibrillation episodes to the pacemaker detected atrial fibrillation episodes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The modified Microlife blood pressure monitor is able to detect atrial fibrillation (AF) with high sensitivity (95%) and specificity (86%) and has a positive predictive value of 68% and negative predictive value of 98% for single readings. In addition, the modified device was also able to accurately classify the majority of the anomalous non-AF rhythms, although the specificity was highly variable, dependent upon the rhythm. However sinus rhythm was detected with a specificity of 97%. However, we do not currently know if the device would demonstrate a similar sensitivity in detecting AF in patients with paroxysmal AF.

Therefore, the present study will assess the sensitivity and specificity of the automated oscillometric device using a new AF algorithm among pacemaker patients with fast AF and atrial high-rate episodes and evaluate the effect of the specific rhythm abnormalities on the specificity for AF.

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B18 7QH
        • Sandwell and West Birmingham Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who have an implanted pacemaker for sick sinus syndrome with previously documented AF with atrial high-rate episodes, with be identified from the pacemaker clinic register at one NHS Trust. Patients with AF and one of the following pacemakers will be identified from this register: Medtronic Sensia DR, Medtronic Advisa DR, Sorin Reply DR, and St. Jude Medical Accent DR and the study population will be randomly drawn from these patients. Atrial high rate episodes will be defined as atrial rates ≥180 beats per minute [3-6]. The exclusion criteria will include any patient who's pacemaker has had previously documented atrial sensing or pacing problem issues and patients with permanent AF.

Description

Inclusion Criteria:

  • Patients with an implanted pacemaker for sick sinus syndrome with previously documented AF with atrial high-rate episodes

Exclusion Criteria:

  • Any patient who's pacemaker has had previously documented atrial sensing or pacing problem issues
  • Patients with permanent AF

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients who are identified as having atrial fibrillation by both the pacemaker and the Microlife device (%)
Time Frame: 24 hours
True positive rate (sensitivity)
24 hours
Percentage of patients who are identified as not having atrial fibrillation by both the pacemaker and the Microlife device (%)
Time Frame: 24 hours
True negative rate (specificity)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Collaborators

Sandwell & West Birmingham Hospitals NHS Trust

Investigators

  • Principal Investigator: Gregory YH Lip, MD, University of Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

May 1, 2015

First Submitted That Met QC Criteria

May 8, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG_13-114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

IPD in an anonymised form can be made able upon direct request.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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