NCT01867060

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

2.3 years

First QC Date

May 29, 2013

Last Update Submit

April 24, 2017

Conditions

Paroxysmal Atrial FibrillationStroke

Keywords

Cardiac monitoringBiomarkersTransthoracic echocardiography

Outcome Measures

Primary Outcomes (1)

  • The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect all episodes of paroxysmal atrial fibrillation.

    18 months

Secondary Outcomes (8)

  • The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect prolonged episodes of paroxysmal atrial fibrillation (defined as greater than 12 hours).

    18 months

  • The sensitivity and specificity of serum biomarkers to detect cases of PAF.

    18 months

  • The sensitivity and specificity of markers of left atrial function to predict PAF.

    18 months

  • The development of AF in a cohort confirmed to have frequent atrial ectopic beats (APBs) over a one year period.

    18 months

  • Adverse events (including stroke/TIA, myocardial infarction, significant bleeding events and death) at six and twelve month intervals.

    30 months

  • +3 more secondary outcomes

Study Arms (1)

Personal Heart Rhythm Monitor

OTHER

Automated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor.

Device: Automated Cardiac Event RecorderDevice: Personal Heart Rhythm Monitor

Interventions

Automated Cardiac Event RecorderDEVICE

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

Also known as: 'R. Test Evolution 4' (Novacor).
Personal Heart Rhythm Monitor
Personal Heart Rhythm MonitorDEVICE

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

Also known as: 'Portable ECG monitor HCG-801' (OMRON Healthcare).
Personal Heart Rhythm Monitor

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Suspected paroxysmal AF (either palpitations consistent with AF or an irregular pulse)
  • lead resting ECG confirming sinus rhythm
  • Capacity to consent to study
  • English-speaking
  • Life expectancy at least one year

You may not qualify if:

  • Previous diagnosis of AF
  • Recent history of syncope
  • Recent history of cardiac-sounding chest pain
  • A resting ECG suggestive of alternative arrhythmia
  • Inability to use the telephone
  • Thyrotoxicosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Surrey County Hospital NHS Foundation Trust

Guildford, Surrey, GU2 7XX, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Atrial FibrillationStroke

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Philippa Howlett, MBChB BSc

    The Royal Surrey County Hospital

    PRINCIPAL INVESTIGATOR

  • Edward Leatham, MBChB MD

    The Royal Surrey County Hospital

    STUDY DIRECTOR

  • Chris Fry, BSc PhD

    The University of Surrey

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 3, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2016

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

GB(1)