Device-detected Paroxysmal Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02442505
• Lead Sponsor: University of Birmingham

Brief Summary

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.

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2015-05-01
• Study First Submitted QC: 2015-05-08
• Study First Posted: 2015-05-13
• Status Verified: 2018-05
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sandwell and West Birmingham Hospitals NHS Trust; 🇬🇧 Birmingham, West Midlands, United Kingdom