Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cardiocity Limited
ClinicalTrials.gov Identifier:
NCT02401451
First received: March 24, 2015
Last updated: August 9, 2016
Last verified: August 2016
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Device: RhythmPadGP

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: SL-AF Trial - (Six Lead Identification of Atrial Fibrillation [AF])

Resource links provided by NLM:


Further study details as provided by Cardiocity Limited:

Primary Outcome Measures:
  • Six Lead Identification of Atrial Fibrillation [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 750
Study Start Date: October 2014
Study Completion Date: May 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ECG acquisition

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
ECG acquisition using a novel device RhythmPadGP

Detailed Description:

The concept for the Rhythm Pad is to screen the public non-invasively for a cardiac rhythm abnormality, every time that they interact with a clinician. Cardiocity have conducted significant trialing of the RhythmPad product within both the primary care setting at the Old Cottage Hospital in Epsom and in a secondary care setting at St Peter's Hospital in Chertsey. The initial results were encouraging with a simple hand screening providing an indication of AF in 66% of the confirmed cases of AF, when verified by a traditional electrocardiogram (ECG) known as a GE MAC550 12 lead device as the benchmark.

The main aim is for the RhythmPad range of products to increase the ability to diagnose cardiac rhythm abnormalities, along with reducing the number of false positive referrals to secondary care for a 12 lead Electrocardiogram of ECG. As such confirming the diagnosis before referral reduces the number of false positive referrals. If one of our algorithms thinks that there is evidence that the person might be in a state of Atrial Fibrillation (AF), Flutter, might have left or right bundle branch block, etc, then by moving to the 6 lead we are able to increase the confidence of the diagnosis.

The RhythmPad is now able to support a 6 lead ECG acquisition, this is by using a modified device called the RhythmPadGP as such we would plan to trial this technology with St Peter's Hospital. We have learnt from the experiences of the previous trails. We know that 5% of the entire population will not have strong enough Lead 1 ECG when measured from their hands. Also those with Essential Tremor, Parkinson's etc. are not able to keep their hands steady for an accurate reading to be taken. In such cases, or as an escalation from the one lead data, we now offer through a simple Velcro ankle strap attachment the ability to record 6 leads of data.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02401451

Locations
United Kingdom
Ashford and St Peters NHS Trust
Surrey, United Kingdom
Sponsors and Collaborators
Cardiocity Limited
Investigators
Principal Investigator: Riyaz A Kaba, MBBS Ashford and St Peter's Hospitals NHS Foundation Trust
  More Information

Responsible Party: Cardiocity Limited
ClinicalTrials.gov Identifier: NCT02401451     History of Changes
Obsolete Identifiers: NCT02124629
Other Study ID Numbers: ACB1-1001-1941 
Study First Received: March 24, 2015
Last Updated: August 9, 2016
Health Authority: United Kingdom: National Health Service
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 23, 2016