Clinical trial NCT01917981: Testing the Accuracy of a Personal Heart Rhythm Monitor to Detect Prolonged Paroxysmal Atrial Fibrillation
Official title: Testing the Accuracy of an Intermittent Personal Heart Rhythm Monitor (PHRM) to Detect Prolonged Paroxysmal Atrial Fibrillation (PAF) Against Implantable Devices.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Paroxysmal Atrial Fibrillation
Stroke
Keywords: Intermittent cardiac monitoring
Implantable device
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: Royal Surrey County Hospital NHS Foundation Trust
name: Ashford and St. Peter's Hospitals NHS Trust
First posted: 2013-08-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: The sensitivity and specificity of detection of prolonged paroxysmal atrial fibrillation (PAF) using a Personal Heart Rhythm Monitor (PHRM), compared to an implantable device.
timeFrame: 18 months
Secondary outcomes:
measure: The sensitivity and specificity of detection of all episodes of PAF using a PHRM, compared to an implantable device.
timeFrame: 18 months
measure: Participant compliance with twice-daily recordings with the PHRM for a three month period.
timeFrame: 18 months
measure: The concordance of the interpretation of PHRM recordings by a Research Nurse and blinded Cardiologist.
timeFrame: 18 months
Other outcomes:
Locations:
city: Chertsey
country: United Kingdom
facility: St Peter's Hospital
state: Surrey
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital NHS Foundation Trust
state: Surrey
Study officials:
affiliation: The University of Surrey and The Royal Surrey County Hospital
name: Philippa J Howlett, MBChB MRCP
role: PRINCIPAL_INVESTIGATOR
References: