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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02401451
Recruitment Status : Completed
First Posted : March 27, 2015
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Cardiocity Limited

Tracking Information
First Submitted Date  ICMJE March 24, 2015
First Posted Date  ICMJE March 27, 2015
Last Update Posted Date August 10, 2016
Study Start Date  ICMJE October 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2015)
Six Lead Identification of Atrial Fibrillation [ Time Frame: 9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02401451 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SL-AF Trial - (Six Lead Identification of Atrial Fibrillation [AF])
Official Title  ICMJE SL-AF Trial - (Six Lead Identification of Atrial Fibrillation [AF])
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Device: RhythmPadGP
ECG acquisition using a novel device RhythmPadGP
Study Arms  ICMJE 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'

Intervention: Device: RhythmPadGP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2016)
750
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2015)
550
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02401451
Other Study ID Numbers  ICMJE ACB1-1001-1941
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cardiocity Limited
Study Sponsor  ICMJE Cardiocity Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Riyaz A Kaba, MBBS Ashford and St Peter's Hospitals NHS Foundation Trust
PRS Account Cardiocity Limited
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP