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Six Lead Identification of Atrial Fibrillation (SL-AF)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Ashford and St. Peter's Hospitals NHS Trust
Sponsor:
Information provided by (Responsible Party):
Ashford and St. Peter's Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT02124629
First received: April 25, 2014
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

Atrial Fibrillation (AF) is the most common cardiac rhythm disturbance or arrhythmia. It is more common as you get older and is a major risk factor for stroke. Often AF has minimal symptoms and so diagnosing it may be difficult. Often if a GP suspects a cardiac rhythm problem, they may ask for an electrocardiogram (ECG).

A 12 lead ECG is the gold-standard for diagnosing AF, however, it is not the most convenient process for patients or technicians. It requires removal of clothes and possibly body hair. Also the attachment of multiple leads for a standard 12-lead ECG recording often results in detachment of one or more of the adhesive leads, requiring repositioning and delays in the process.

Novel ways of diagnosing AF are therefore needed. The RhythmPadGP does not have the same practical limitations as the standard 12-lead ECG system and requires the placement of three straps (one around each wrist and one around an ankle); this is likely to be more acceptable to patients and technicians.

The RhythmPadGP is a novel technology and investigation is required to assess if it is an accurate method for screening for AF.


Condition Intervention
Atrial Fibrillation
Atrial Flutter
Bradycardia
Tachycardia
Tachycardia, Supraventricular
Device: RhythmPadGP

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Study to Examine the Diagnositic Capability of a Novel Six Lead Electrocardiogram (ECG) Recording Using the RhythmPadGP, Compared to a Concurrently Taken Lead 1 Recording, and a Traditional 12 Lead ECG System.

Resource links provided by NLM:


Further study details as provided by Ashford and St. Peter's Hospitals NHS Trust:

Primary Outcome Measures:
  • Number of participants with a diagnosis of Atrial Fibrillation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will assess the 6 lead recording using investigators blinded to other recordings and see if AF is recognized


Secondary Outcome Measures:
  • Number of participants with a diagnosis of atrial flutter [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Including a comparison of the different lead recordings (ie 1 lead, 6 lead and 12 lead)

  • Number of participants with a diagnosis of tachycardia (heart rate greater the 100 beats per minute) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Including a comparison of the different lead recordings (ie 1 lead, 6 lead and 12 lead)

  • Number of participants with a diagnosis of bradycardia (heart rate less then 50 beats per minute) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Including a comparison of the different lead recordings (ie. 1 lead, 6 lead and 12 lead)

  • Accurate diagnosis of supraventricular tachycardia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Including a comparison of the different lead recordings (ie 1 lead, 6 lead and 12 lead)

  • Number of participants with a diagnosis of atrial or ventricular ectopy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Including a comparison of the different lead recordings (ie 1 lead, 6 lead and 12 lead)


Other Outcome Measures:
  • Number of patients that find the use of the RhythmPadGP device acceptable [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As found by a predetermined questionnaire asking them to ask whether they found the device acceptable and if they had any problems with it


Estimated Enrollment: 550
Study Start Date: July 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RhythmPadGP
Patients will have a 12 lead ECG taken and its findings will be compared to the RhythmPadGP
Device: RhythmPadGP
Patients will have a six lead electrocardiogram recorded. This will involve having three Velcro straps attached to their limbs (one around each wrist and one around an ankle). There are non invasive.
Other Name: Six lead electrocardiogram

Detailed Description:

We hope to recruit 550 patients from those attending St Peters Hospital over a 6 month period.

Patients will be selected from those arriving at the electrocardiogram (ECG) department for a standard 12 lead ECG recording, or from those attending the cardiology outpatient department.

Whilst the participants are waiting for their ECGs, a research nurse trained in good clinical practice will give them an ethically approved information leaflet outlining the study. For those attending clinic, the same information sheet will also be posted out to them in advance.

Once they have taken the time to read the information leaflet a research nurse or doctor will be available to answer any questions. Formal consent will then be sought for inclusion in the study, and will be gained by a member of the research department trained in gaining informed consent.

Whilst having their 12-lead ECG, the patients shall also have 3 Velcro straps attached; 1 on each wrist and 1 around an ankle. As they are having the standard 12-lead ECG performed (as was requested by their health care professional), the additional 3 lead (Velcro straps) system will make separate recordings (a 6 lead and 1 lead recording). Owing to the simplicity of the trial 3-lead system and undertaking the recordings simultaneously, the time to perform the additional recordings shall not be significantly greater than the standard process.

A patient experience questionnaire shall be undertaken. A standardized checklist will be used to confirm that we have the 1 lead, 6 lead and 12 lead recordings for the same patient. This will be completed at the time of the recordings and further monitored on a weekly basis.

After the data is collected from the participants it will be analysed independently by doctors and cardiac physiologists who are blinded to the concurrent recordings. Any uncertain or discordant findings will be reviewed by a cardiologist blinded to all findings.

The findings of the 6 lead device will be analyzed and the diagnostic rates, sensitivity and specificity of recordings will be calculated in comparison to the 12 lead gold standard. Further analysis will take place comparing a 1 lead recording, and looking at other findings such as atrial flutter, supraventricular tachycardia, tachycardia, bradycardia and sinus rhythm. The patient experience data shall be analyzed for inclusion in the results.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
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 St Peters Hospital Chertsey for an electrocardiogram
  • No known allergies to the Velcro or metal used in the RhythmaPadGP 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 RhythmPadGP leads
  • Those with pacemakers or other implanted cardiac devices that would interfere with the electrocardiogram 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: NCT02124629

Contacts
Contact: Isaac John, PhD 01932872000 ext 2901 isaac.john@asph.nhs.uk
Contact: Riyaz A Kaba, MBBS 01932723534 riyaz.kaba@nhs.net

Locations
United Kingdom
Ashford & St. Peters Hospital Not yet recruiting
London, United Kingdom, KT16 0PZ
Contact: Isaac John, PhD    01932872000 ext 2901    isaac.john@asph.nhs.uk   
Contact: freda Gomes       freda.gomes@asph.nhs.uk   
Sub-Investigator: Omar Ahmed, MBBS         
Sub-Investigator: Chris Crockford, PhD         
Sponsors and Collaborators
Ashford and St. Peter's Hospitals NHS Trust
Investigators
Principal Investigator: Riyaz A Kaba, MBBS Ashford & St Peters Hospital, Epsom General Hospital, St. Georges Hospital
  More Information

No publications provided

Responsible Party: Ashford and St. Peter's Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02124629     History of Changes
Other Study ID Numbers: 2014RAK02
Study First Received: April 25, 2014
Last Updated: July 23, 2014
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Ashford and St. Peter's Hospitals NHS Trust:
Atrial Fibrillation
Electrocardiogram
Arrhythmia

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Bradycardia
Tachycardia
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014