Device-detected 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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Hypersensitivity Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sandwell and West Birmingham Hospitals NHS Trust

Birmingham, West Midlands, B18 7QH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microlife WatchBP03 device

Device

Microlife WatchBP03 device which is an automated oscillometric device using a new algorithm to detect atrial fibrillation

Primary outcomes

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)
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)

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Collaborators

Sandwell & West Birmingham Hospitals NHS Trust

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2018
First posted: May 13, 2015
Registry last updated: Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed