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

NCT02401451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2016-08-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

RhythmPadGP

ECG acquisition using a novel device RhythmPadGP

Sponsors & Collaborators

  • Cardiocity Limited

    lead INDUSTRY

Principal Investigators

  • Riyaz A Kaba, MBBS · Ashford and St Peter's Hospitals NHS Foundation Trust

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-03-31
Completion
2016-05-31

Countries

  • United Kingdom

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02401451 on ClinicalTrials.gov