NCT02956343

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
651

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

November 2, 2016

Last Update Submit

January 12, 2018

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationcardiovascular AppRhythm monitoringStroke prevention

Outcome Measures

Primary Outcomes (1)

  • Correct detection of AF

    Sensitivity and specificity of the Preventicus Heartbeats App to distinguish between AF and SR

    5 minutes

Secondary Outcomes (2)

  • Differences in correct detection of AF between Smartwatch and Wristband

    5 minutes

  • Reduced sensitivity and specificity in patients with >2% premature beats

    5 minutes

Study Arms (2)

AF

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

Device: Five minutes pulse wave recording

SR

Five minutes pulse wave recording in patients with sinus rhythm at the time of recruitment

Device: Five minutes pulse wave recording

Interventions

Five minutes pulse wave recordingDEVICE

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.

AFSR

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients at the University Hospital Basel

You may qualify if:

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

You may not qualify if:

  • Legally incompetent persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin B

Greifswald, 17475, Germany

Location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 27371660RESULT

  • 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.

    PMID: 30784691DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jens Eckstein, MD, PhD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 7, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 16, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)DE(1)