Device-detected Paroxysmal Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442505
• Other study ID #: RG_13-114
• Status: Completed
• Start date: October 2013
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Sandwell and West Birmingham Hospitals NHS Trust	Birmingham	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	Sandwell & West Birmingham Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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