Device-detected Paroxysmal Atrial Fibrillation

NCT ID: NCT02442505

Last Updated: 2019-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Microlife WatchBP03 device

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sandwell & West Birmingham Hospitals NHS Trust

OTHER

Sponsor Role collaborator

University of Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory YH Lip, MD

Role: PRINCIPAL_INVESTIGATOR

University of Birmingham

Locations

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Sandwell and West Birmingham Hospitals NHS Trust

Birmingham, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RG_13-114

Identifier Type: -

Identifier Source: org_study_id

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