Comparing the Rapid Rhythm System to 12-Lead ECG to identify older patients with atrial fibrillation in primary care

A diagnostic accuracy study comparing the use of the Rapid Rhythm System to 12-Lead ECG to identify atrial fibrillation in over 65s in primary care

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN12144707

Enrollment

1000

Registered

2016-07-29

Start date

2016-10-07

Completion date

Unknown

Last updated

2021-06-07

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

Conditions

Atrial Fibrillation Circulatory System Atrial Fibrillation

Interventions

The study involves screening patients for presence of atrial fibrillation using the Rapid Rhythm System and the current gold standard 12-lead ECG. The study is not randomised and no follow up is requi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients over the age of 65, including those with prior atrial fibrillation diagnoses.

Exclusion criteria

Exclusion criteria: 1. Patients with implanted pacemakers, or defibrillators 2. Those unable to provide informed consent 3. Those considered by GPs to be inappropriate (e.g. due to terminal illness)

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of the ECG trace from the Rapid Rhythm System at identifying atrial fibrillation (AF) compared to the ECG trace from the 12-lead is determined through assessing the sensitivity (ability to correctly identify patients with AF) and specificity (ability to correctly identify those without AF) of the RR compared to the Gold Standard 12-lead ECG, based on the diagnosis decisions made by the expert cardiology panel from the ECG traces from each system. Both ECG traces will be taken at the same time point and no follow up is involved.	—

Measure

Time frame

Diagnostic accuracy of the ECG trace from the Rapid Rhythm System at identifying atrial fibrillation (AF) compared to the ECG trace from the 12-lead is determined through assessing the sensitivity (ability to correctly identify patients with AF) and specificity (ability to correctly identify those without AF) of the RR compared to the Gold Standard 12-lead ECG, based on the diagnosis decisions made by the expert cardiology panel from the ECG traces from each system. Both ECG traces will be taken at the same time point and no follow up is involved.

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Secondary

Measure	Time frame
Secondary accuracy measures: Positive and negative predictive values (percentages confirmed by the 12-lead ECG to have/not have AF, out of all those classified as such using the RR). An additional analysis will be conducted to compare the findings from the RR and 12-lead ECG to any pre-existing diagnoses of AF, taking from each patient’s medical record. A further analysis will make a comparison between two different configurations for the RR device. The device can be operated as either 8-lead from the handset alone or 12-lead using the handset with chest lead attachment. This is an adjunct technical analysis of device characteristics, not a performance measure. For this purpose the 8-lead data will be extracted from the full 12-lead and results for the two configurations compared using correlational and other analysis to determine the extent of agreement across the variables: 1. Rate 2. R-R interval 3. PR interval 4. QRS duration 5. QT interval 6. P-wave frontal axis 7. QRS-frontal axis 8. T-wave frontal axis 9. R/S amplitude in V1 and V2 10. R/S ratio in V1 and V2	—

Measure

Time frame

Secondary accuracy measures: Positive and negative predictive values (percentages confirmed by the 12-lead ECG to have/not have AF, out of all those classified as such using the RR). An additional analysis will be conducted to compare the findings from the RR and 12-lead ECG to any pre-existing diagnoses of AF, taking from each patient’s medical record. A further analysis will make a comparison between two different configurations for the RR device. The device can be operated as either 8-lead from the handset alone or 12-lead using the handset with chest lead attachment. This is an adjunct technical analysis of device characteristics, not a performance measure. For this purpose the 8-lead data will be extracted from the full 12-lead and results for the two configurations compared using correlational and other analysis to determine the extent of agreement across the variables: 1. Rate 2. R-R interval 3. PR interval 4. QRS duration 5. QT interval 6. P-wave frontal axis 7. QRS-frontal axis 8. T-wave frontal axis 9. R/S amplitude in V1 and V2 10. R/S ratio in V1 and V2

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Countries

United Kingdom

Contacts

Public ContactJonathan Lamb

Outcome results

None listed

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