Device-detected Paroxysmal Atrial Fibrillation

NCT02442505 | Completed

• 1 other identifier: RG_13-114
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Pacemaker; Device-detected; Sensitivity; Specificity

Outcome Measures

Primary Outcomes (2)

• Percentage of patients who are identified as having atrial fibrillation by both the pacemaker and the Microlife device (%)

  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 (%)

  True negative rate (specificity)

  24 hours

Interventions

Microlife WatchBP03 device DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Birmingham: lead
• Sandwell & West Birmingham Hospitals NHS Trust: collaborator

Study Sites (1)

Sandwell and West Birmingham Hospitals NHS Trust

Birmingham, West Midlands, B18 7QH, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation; Hypersensitivity

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Gregory YH Lip, MD

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: May 13, 2015
• Study Start: October 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 19, 2019

Record last verified: 2018-05

Locations

GB (1)