Paroxysmal Atrial Fibrillation, Stroke
Conditions
Keywords
Intermittent cardiac monitoring, Implantable device
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.
Interventions
Sponsors
Royal Surrey County Hospital NHS Foundation Trust
Ashford and St. Peter's Hospitals NHS Trust
University of Surrey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United Kingdom
Outcome results
None listed