SMARTHEART Validation Study

• Research type

  Research Study

• Full title

  SMARTHEART validation study - A study to assess the accuracy and validate novel smartphone and wearable ECG devices in cardiovascular patients

• IRAS ID

  253737

• Contact name

  G. Andre Ng

• Contact email

  andre.ng@le.ac.uk

• Sponsor organisation

  University of Leicester

• Clinicaltrials.gov Identifier

  113853, UHL R&I EDGE

• Duration of Study in the UK

  1 years, 4 months, 18 days

• Research summary

  A large proportion of cardiology outpatients clinic referrals are for patients presenting with symptoms suggestive of arrhythmia. In order to make a diagnosis, correlation of symptoms with an ECG recording of the heart rhythm is usually required. This is particularly difficult in patients with infrequent symptoms, as it is difficult to predict when symptoms will occur and therefore when to arrange for the patient to have an ECG. The ability for patients to accurately record their own ECGs in the community using novel smartphone or wearable ECG devices, could provide a significant benefit to patients and the NHS, as it will reduce unnecessary or non-diagnostic investigations, and improve diagnostic yield with shorter time to diagnosis.

  Wearable technologies are cheap and increasingly more popular. They are available for patients to buy from the retail market and use without prescription. This has led to a market where devices that are not fully validated are used by patients. They are also used in and out of hospital environments where other factors could affect accuracy. Robust clinical studies are needed to prove the validity and accuracy of data that could potentially be used for clinical diagnoses. Current CE marking requirements do not fully address this.

  This study compares a range of smartphone or wearable ECG devices to a gold standard hospital ECG.

  The smartphone or wearable devices used will include the following:
  • Apple watch series 4
  • AliveCor Kardia Band
  • SnapECG
  • Wiwi ECG
  • Micor A100
  • Alivecor Kardia Mobile
  • JSK-P3 Smart HRM Bracelet

  The accuracy and acceptability of the devices will be tested in 128 inpatients with normal and abnormal baseline ECGs. In turn, each wearable ECG device will be used to record the patient's heart rhythm simultaneously with the gold standard ECG. We will assess the impact of movement, posture, and skin condition. In addition to analysis of the ECGs, the patients will be invited to complete a questionnaire detailing their opinions of the novel ECG devices.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  19/SC/0151

• Date of REC Opinion

  17 May 2019

• REC opinion

  Further Information Favourable Opinion