Atrial FibrillationWATCHAFNCT02956343
SmartWATCHes for Detection of Atrial Fibrillation
An observational study of Atrial Fibrillation, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Five minutes pulse wave recording
- Type of treatment
- Medical device
- How many people
- 651 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients at the University Hospital Basel
Who may be able to join
- Subjects of legal age,
- patients with either sinus rhythm (Group SR) or atrial fibrillation (Group AF)
- signed informed consent form
Who cannot join
- Legally incompetent persons
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin B
Greifswald, 17475
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
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.
Read the 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
- Being tested
- Five minutes pulse wave recording
- Keywords
- Atrial fibrillation, cardiovascular App, Rhythm monitoring, Stroke prevention
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| AF | Five minutes pulse wave recording in patients with atrial fibrillation at the time of recruitment Receives: Device: Five minutes pulse wave recording | |
| SR | Five minutes pulse wave recording in patients with sinus rhythm at the time of recruitment Receives: Device: Five minutes pulse wave recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct detection of AF
Sensitivity and specificity of the Preventicus Heartbeats App to distinguish between AF and SR
Measured: 5 minutes
Secondary outcomes (2)
Differences in correct detection of AF between Smartwatch and Wristband
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.
Measured: 5 minutes
Reduced sensitivity and specificity in patients with >2% premature beats
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Greifswald
- Responsible party
- Sponsor
- Investigators
- Jens Eckstein, MD, PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956343
- Sponsor's protocol ID
- 2016-01175
- Other IDs
- 2016
- Acronym
- WATCHAF
- Status last verified
- Jan 2018
- First submitted
- 2 Nov 2016
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27371660Dorr 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.
PubMed 30784691
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SmartWATCHes for Detection of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02956343
- Acronym / sponsor ID
- WATCHAF / 2016-01175
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, cardiovascular App, Rhythm monitoring, Stroke prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University Hospital Greifswald
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF | – | Device: Five minutes pulse wave recordingFive minutes pulse wave recording in patients with atrial fibrillation at the time of recruitment |
| SR | – | Device: Five minutes pulse wave recordingFive minutes pulse wave recording in patients with sinus rhythm at the time of recruitment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the University Hospital Basel
Key inclusion criteria (3 listed)
- Subjects of legal age,
- patients with either sinus rhythm (Group SR) or atrial fibrillation (Group AF)
- signed informed consent form
Key exclusion criteria (1 listed)
- Legally incompetent persons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Five minutes pulse wave recordingPatients 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. | Device | AF, SR |
Primary outcome
Correct detection of AF
Time frame: 5 minutes
Sensitivity and specificity of the Preventicus Heartbeats App to distinguish between AF and SR
2 secondary outcomes
Differences in correct detection of AF between Smartwatch and Wristband
Time frame: 5 minutes
Reduced sensitivity and specificity in patients with >2% premature beats
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Results publication: PubMed 27371660Krivoshei 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.
- Derived from this study: PubMed 30784691Dorr 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.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Eckstein, MD, PhD principal investigator
University Hospital, Basel, Switzerland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct detection of AF (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02956343, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.