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SmartWATCHes for Detection of Atrial Fibrillation (WATCHAF)

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ClinicalTrials.gov Identifier: NCT02956343
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
University Hospital Greifswald
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
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.

Condition or disease Intervention/treatment
Atrial Fibrillation Device: Five minutes pulse wave recording

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.


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Study Type : Observational
Actual Enrollment : 651 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: SmartWATCHes for Detection of Atrial Fibrillation
Study Start Date : December 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Correct detection of AF [ Time Frame: 5 minutes ]
    Sensitivity and specificity of the Preventicus Heartbeats App to distinguish between AF and SR


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients at the University Hospital Basel
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956343


Locations
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Germany
Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin B
Greifswald, Germany, 17475
Switzerland
University Hospital Basel
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University Hospital Greifswald
Investigators
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Principal Investigator: Jens Eckstein, MD, PhD University Hospital, Basel, Switzerland

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02956343     History of Changes
Other Study ID Numbers: 2016-01175
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Basel, Switzerland:
Atrial fibrillation
cardiovascular App
Rhythm monitoring
Stroke prevention

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