SmartWATCHes for Detection of Atrial Fibrillation (WATCHAF)

January 12, 2018 updated by: University Hospital, Basel, Switzerland
In this trial the Preventives Heartbeats algorithm will be tested in two wearable devices for its specificity and sensitivity to distinguish between AF and SR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction

Particularly in stroke prevention, the detection of atrial fibrillation is of pivotal importance. Recent studies have impressively confirmed the merits of long-term monitoring. Nevertheless, and despite very mature technology, the currently available methods like long-term ECG with conductive adhesive electrodes or implantable loop recorders are burdened with disadvantages in that they are inconvenient, costly and/or invasive. A predecessor study gave us the possibility to test an app that employs photoplethysmographic signals on a smartphone camera-similar to pulse oximetry technology-to distinguish between atrial fibrillation and sinus rhythm. That retrospective study achieved a sensitivity and specificity of 95% (Krivoshei et al., Europace 2016). The prospective follow-up study DETECT AF pro is currently being conducted in cooperation with Prof. Dörr in Greifswald, Germany.

Our research group has been involved with testing the app's quality in clinical settings before implementing it for use. This procedure differs markedly from the otherwise common practice of marketing qualitatively inferior "health apps" without any clinical testing. There is no app equipped with comparable technology worldwide. The WATCH AF study is the first study on sophisticated rhythm analysis using a smartwatch worldwide.

Study design

Prospective, blinded, multicenter study.

The blinded data will be evaluated and monitored externally.

An interim analysis to assess signal quality will be performed after inclusion of 50% of the planned subjects. If there are <10% non-evaluable signals, the number of subjects will be adjusted accordingly. The aim is to enroll 600 evaluable subjects.

Methods

The subjects will be asked to place a smartwatch on each arm to allow their pulse curve to be recorded for five minutes. At the same time, an ambulatory ECG system will take a synchronous ECG for reference. The ECG system employed is equipped with a validated automatic atrial fibrillation detector, used as a reference for assignment to groups. Data will be collected on person-related information, comorbidities and medication (estimated overall duration/patient <20 min). No follow-up is planned. Analogous to predecessor studies, the pulse wave curve data are coded with the patient's identification number (ID) and externally analyzed at Preventicus; based on the results, the patients will be assigned to SR/AF groups. After evaluation of all files, the grouped results will be aggregated, unblinded and evaluated under monitoring.

Primary target parameters are the app's sensitivity and specificity in correctly detecting atrial fibrillation compared to an automatically interpreted ECG.

Secondary target parameters include the proportion of non-evaluable recordings in the overall study, differences between the two smartwatches and the app's sensitivity and specificity in patients with >2% premature beats.

Study Type

Observational

Enrollment (Actual)

651

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Greifswald, Germany, 17475
        • Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin B
  • Switzerland
    • BS
      • Basel, BS, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients at the University Hospital Basel

Description

Inclusion Criteria:

  • Subjects of legal age,
  • patients with either sinus rhythm (Group SR) or atrial fibrillation (Group AF)
  • signed informed consent form

Exclusion Criteria:

  • Legally incompetent persons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AF
Five minutes pulse wave recording in patients with atrial fibrillation at the time of recruitment
Device: Five minutes pulse wave recording
Patients will wear a smart watch and a wristband each at one arm. A standard egg (lead I) and pig signals from the wearables will be recorded for five minutes.
SR
Five minutes pulse wave recording in patients with sinus rhythm at the time of recruitment
Device: Five minutes pulse wave recording
Patients will wear a smart watch and a wristband each at one arm. A standard egg (lead I) and pig signals from the wearables will be recorded for five minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correct detection of AF
Time Frame: 5 minutes
Sensitivity and specificity of the Preventicus Heartbeats App to distinguish between AF and SR
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in correct detection of AF between Smartwatch and Wristband
Time Frame: 5 minutes
Smartwatch and Wristband will be worn simultaneously. As there is no difference in rhythm between left and right lower arm it will be analyzed if there are differences in the primary outcome between the two devices.
5 minutes
Reduced sensitivity and specificity in patients with >2% premature beats
Time Frame: 5 minutes
Patients in the SR group will be screened for premature beats. The ones with >2% will be taken for an second analysis to validate if the sensitivity of the algorithm is less good for patients with a high number of premature beats.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

University Hospital Greifswald

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 6, 2016

Study Record Updates

Last Update Posted (Actual)

January 16, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-01175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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