Testing the Accuracy of a Personal Heart Rhythm Monitor to Detect Prolonged Paroxysmal Atrial Fibrillation

Withdrawn

Phase 3 Results N/A

Trial Description

This study aims to determine the sensitivity and specificity of a Personal Heart Rhythm Monitor in the detection of prolonged paroxysmal atrial fibrillation (defined as lasting more than 12 hours) against pre-existing implantable devices, seen to be the 'gold-standard' for arrhythmia detection.

Detailed Description

The Investigators aim to recruit 30 volunteers with implantable devices (either conventional pacemakers, with an atrial lead or implantable loop recorders, devices inserted under the skin to monitor the heart rhythm). They will be attending for their routine pacemaker checks in a number of clinics in Surrey.
Potential participants will have documented prolonged paroxysmal atrial fibrillation (PAF, an intermittent irregular heart rhythm which is known to predispose to stroke), lasting at least 12 hours, identified in the last month prior to the pacemaker check.
Willing patients will then be issued with a PHRM (Personal Heart Rhythm Monitor) device to make heart rhythm recordings for 3 months. They will do this twice-daily for 30 seconds for this period. At the end of the 3 month period patients will undergo a final pacing device check. Identification of prolonged PAF using the PHRM device will be compared to the implantable device.

Trial Stopped: Failure to recruit.

Conditions

Interventions

  • Personal Heart Rhythm Monitor Device
    Other Names: 'Portable ECG monitor HCG-801' (OMRON Healthcare).
    ARM 1: Kind: Experimental
    Label: Personal Heart Rhythm Monitor
    Description: Intermittent cardiac monitoring with a Personal Heart Rhythm Monitor for three months.

Trial Design

  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Diagnostic
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The sensitivity and specificity of detection of prolonged paroxysmal atrial fibrillation (PAF) using a Personal Heart Rhythm Monitor (PHRM), compared to an implantable device. 18 months No
Secondary The sensitivity and specificity of detection of all episodes of PAF using a PHRM, compared to an implantable device. 18 months No
Secondary Participant compliance with twice-daily recordings with the PHRM for a three month period. 18 months No
Secondary The concordance of the interpretation of PHRM recordings by a Research Nurse and blinded Cardiologist. 18 months No

Sponsors