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

NCT02401451 | Completed

• 1 other identifier: ACB1-1001-1941
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Six Lead Identification of Atrial Fibrillation

  9 months

Study Arms (1)

ECG acquisition

EXPERIMENTAL

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

Device: RhythmPadGP

Interventions

RhythmPadGP DEVICE

ECG acquisition using a novel device RhythmPadGP

ECG acquisition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiocity Limited: lead

Study Sites (1)

Ashford and St Peters NHS Trust

Surrey, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Riyaz A Kaba, MBBS

  Ashford and St Peter's Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: March 27, 2015
• Study Start: October 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

GB (1)