The use of a hand-held electrocardiogram (ECG) monitor to diagnose paroxysmal atrial fibrillation at high risk of stroke

Validation of a single channel, patient-activated, hand-held electrocardiogram (ECG) device in the diagnosis of paroxysmal atrial fibrillation with high embolic risk

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN06487378

Enrollment

Registered

2011-11-28

Start date

2012-12-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal atrial fibrillation (PAF) Circulatory System Atrial fibrillation and flutter

Interventions

Current interventions as of 05/10/2012: Subjects will be issued with two new methods of ECG monitoring (to be compared with the continuous, implantable ECG monitor already in place). The first method

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 05/10/2012: 1. Age > 18 years 2. Duration of PAF > 24 hours in the last month 3. Capacity to consent to study 4. No new initiation of anti-arrhythmic agents. 5. Pacing less than 25% of time at last pacing check Previous inclusion criteria until 05/10/2012: 1. Age > 65 years 2. Duration of atrial fibrillation > 24 hours in the preceding one month

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 05/10/2012: 1.Inability to use hand-held ECG/R-test due to physical or cognitive impairment Previous exclusion criteria until 05/10/2012: 1. Cognitive impairment (hence inability to use the handheld ECG device)

Design outcomes

Primary

Measure	Time frame
The accuracy of a hand-held ECG device in the diagnosis of paroxysmal atrial fibrillation as compared to a 'gold-standard' implantable continuous monitoring device	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 05/10/2012: 1. The accuracy of a hand-held ECG device compared to a 7-day continuous ECG monitoring device 2. The concordance of diagnosis of atrial fibrillation using all devices between a trained 'arrhythmia nurse' and trained cardiologists 3. The sensitivity and specificity of a novel microRNA biomarker in patients with confirmed PAF. Previous secondary outcome measures until 05/10/2012: 1. The accuracy of a hand-held ECG device compared to a 7-day continuous ECG monitoring device 2. The concordance of diagnosis of atrial fibrillation using all devices between a trained 'arrhythmia nurse' and trained cardiologists	—

Measure

Time frame

Current secondary outcome measures as of 05/10/2012: 1. The accuracy of a hand-held ECG device compared to a 7-day continuous ECG monitoring device 2. The concordance of diagnosis of atrial fibrillation using all devices between a trained 'arrhythmia nurse' and trained cardiologists 3. The sensitivity and specificity of a novel microRNA biomarker in patients with confirmed PAF. Previous secondary outcome measures until 05/10/2012: 1. The accuracy of a hand-held ECG device compared to a 7-day continuous ECG monitoring device 2. The concordance of diagnosis of atrial fibrillation using all devices between a trained 'arrhythmia nurse' and trained cardiologists

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026