SmartWATCHes for Detection of Atrial Fibrillation

NCT ID: NCT02956343

Last Updated: 2018-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 651 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-12-31

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.

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

AF

Five minutes pulse wave recording in patients with atrial fibrillation at the time of recruitment

Five minutes pulse wave recording

Intervention Type: DEVICE

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

Five minutes pulse wave recording

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Greifswald

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens Eckstein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin B

Greifswald, , Germany

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Countries

Germany; Switzerland

References

Krivoshei L, Weber S, Burkard T, Maseli A, Brasier N, Kuhne M, Conen D, Huebner T, Seeck A, Eckstein J. Smart detection of atrial fibrillationdagger. Europace. 2017 May 1;19(5):753-757. doi: 10.1093/europace/euw125.

Reference Type: RESULT

PMID: 27371660 (View on PubMed)

Dorr M, Nohturfft V, Brasier N, Bosshard E, Djurdjevic A, Gross S, Raichle CJ, Rhinisperger M, Stockli R, Eckstein J. The WATCH AF Trial: SmartWATCHes for Detection of Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Feb;5(2):199-208. doi: 10.1016/j.jacep.2018.10.006. Epub 2018 Nov 28.

Reference Type: DERIVED

PMID: 30784691 (View on PubMed)

Other Identifiers

2016-01175

Identifier Type: -

Identifier Source: org_study_id