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

Phase 3

Withdrawn

• Conditions: Paroxysmal Atrial Fibrillation; Stroke
• Interventions: Device: Personal Heart Rhythm Monitor

• Registration Number: NCT01917981
• Lead Sponsor: University of Surrey

Brief 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.

Study Timeline

• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-08-02
• Study First Posted: 2013-08-07
• Study Start: 2013-09
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Prolonged AF (defined as an episode at least 12 hours duration) in the last month whilst attending routine pacemaker check
• Pacing requirement < 25% during the last month

Exclusion Criteria

• Lack of capacity
• Inability to use the Personal Heart Rhythm Monitor due to cognitive or physical impairment
• Commencement of new anti-arrhythmic drug since last pacemaker check

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Personal Heart Rhythm Monitor	Personal Heart Rhythm Monitor	Intermittent cardiac monitoring with a Personal Heart Rhythm Monitor for three months.

Primary Outcome Measures

Name	Time	Method
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	Measured (%) as the number of identified episodes of prolonged PAF using the PHRM compared to the gold standard implantable device in all patients over the 3 month period.

Secondary Outcome Measures

Name	Time	Method
The sensitivity and specificity of detection of all episodes of PAF using a PHRM, compared to an implantable device.	18 months	Measured (%) as the number of identified episodes of all episodes of PAF (lasting at least 30 seconds) using the PHRM compared to the gold standard implantable device in all patients over the 3 month period.
The concordance of the interpretation of PHRM recordings by a Research Nurse and blinded Cardiologist.	18 months	The agreement in the diagnosis of normal sinus rhythm and PAF using PHRM recordings between a Research Nurse and Cardiologist expressed as a percentage.
Participant compliance with twice-daily recordings with the PHRM for a three month period.	18 months	Measured as actual number of recordings made out of 180 requested recordings and expressed as a percentage.

Trial Locations

Locations (2)

Royal Surrey County Hospital NHS Foundation Trust; 🇬🇧 Guildford, Surrey, United Kingdom

St Peter's Hospital; 🇬🇧 Chertsey, Surrey, United Kingdom