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Atrial Fibrillation | SL-AF Trial - (Six Lead Identification of Atrial Fibrillation [AF])

Atrial Fibrillation research study

What is the primary objective of this study?

The 12-lead ECG is an essential tool in cardiovascular assessment. Novel technology has the potential to improve the diagnostic yield of arrhythmias, whilst improving the patient experience. The RhythmPadGP is a novel device which acquires a 6-lead ECG without the need for the patient to undress. The aim of the study is to assess the ability of the device to diagnose cardiac rhythms. Simultaneous recording of the RhythmPadGP 6-lead ECG will be undertaken at the same time as the standard 12-lead ECG. The 12-lead ECGs and 6-lead ECGs will be analysed by a Cardiologist, who will be blinded to each set of ECGs and the automated diagnostic report produced by the RhythmPadGP device. Such a novel diagnostic tool could replace the standard 12-lead ECG for rapid assessment and diagnosis of arrhythmias. Additionally, as calls for a national screening programme to detect atrial fibrillation (and prevent AF-related thromboembolism) currently intensify, the RhythmPad has the potential to revolutionise how we screen our patients.

Who is eligible to participate?

Inclusion Criteria: - Age greater or equal to 18 years of age - able to consent - attending to St Peter's Hospital for an ECG - No known allergies to the velcro or metal used in the RhythmPadGP leads Exclusion Criteria: - Age less than 18 years of age - Not able to consent - Allergies to the metal/velcro strap - Medical condition affecting the wrists that may be interfered with by the attachment of the RhythmPdGP leads, such as a fractured limb that has a cast - Those with pacemakers or other implanted cardiac devices that would interfere with the ECG recording

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Atrial Fibrillation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:RhythmPadGPECG acquisition using a novel device RhythmPadGP

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ECG acquisitionECG acquisition using the standard ECG machine Intervention: An ECG will be performed on every participant using the novel device called the 'RhythmPadGP'

Study Status

Completed

Start Date: October 2014

Completed Date: May 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Six Lead Identification of Atrial Fibrillation

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Riyaz A Kaba, MBBS

Lead Sponsor: Cardiocity Limited

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02401451

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