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Using a Personal Heart Rhythm Monitor to Diagnose Paroxsymal Atrial Fibrillation in the Community

NCT01867060 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2017-04-26

No results posted yet for this study

Summary

This propsective study aims to compare the diagnostic yield of a Personal Heart Rhythm Monitor (PHRM) with an automated cardiac event recorder (ACER) to detect paroxysmal Atrial Fibrillation PAF). The investigators hypothesise that the PHRM, used intermittently for 3 months, will detect significantly more cases of PAF than the ACER, used continuously for one week.

A case-control sub-study will identify individuals with confirmed PAF, and matched individuals with no evidence of PAF, to identify potential serum biomarkers for PAF.

A further case-control study will assess markers of left atrial function in patients with PAF and their matched controls.

Another case-control sub-study will determine the significance of frequent Atrial Premature Beats (APBs) in the development of AF over a one year period.

Conditions

  • Paroxysmal Atrial Fibrillation
  • Stroke

Interventions

DEVICE

Automated Cardiac Event Recorder

Automated Cardiac Event Recorder to be worn continuously for one week.

DEVICE

Personal Heart Rhythm Monitor

Personal Heart Rhythm Monitor to be used twice-daily for three months.

Sponsors & Collaborators

  • Royal Surrey County Hospital NHS Foundation Trust

    collaborator OTHER

  • University of Surrey

    lead OTHER

Principal Investigators

  • Philippa Howlett, MBChB BSc · The Royal Surrey County Hospital

  • Edward Leatham, MBChB MD · The Royal Surrey County Hospital

  • Chris Fry, BSc PhD · The University of Surrey

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-08-31
Completion
2016-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01867060 on ClinicalTrials.gov