NCT01917981

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

Testing the Accuracy of an Intermittent Personal Heart Rhythm Monitor (PHRM) to Detect Prolonged Paroxysmal Atrial Fibrillation (PAF) Against Implantable Devices.

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Surrey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Paroxysmal Atrial Fibrillation
• Stroke

Interventions

Type	Name	Description
DEVICE	Personal Heart Rhythm Monitor

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-08-07
• Last updated: 2017-04-26

Locations

2 sites across 1 country: United Kingdom