Atrial FibrillationDoubleCheckAFNCT04281927

A Wearable With Photoplethysmography and 6-lead Electrocardiography for Atrial Fibrillation Detection

An observational study of Atrial Fibrillation, run by Vilnius University at 1 site in Lithuania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A single center prospective case-control study to evaluate ability of a wearable to differentiate between atrial fibrillation (AF) and sinus rhythm (SR). Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Atrial Fibrillation
What is being tested?: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)
Type of treatment: Medical device
How many people: 435 participants
Where: 1 siteLithuania
Study dates: 6 Mar 2019to 15 Nov 2019
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
No healthy volunteers
Adult, Older adult

Study population: Participants of defined groups will be enrolled in Vilnius University Hospital Santaros Clinics.

Who may be able to join

Participants with current ECG-based diagnosis of atrial fibrillation, sinus rhythm or sinus rhythm with frequent (at least once in 2 minutes) premature atrial or ventricular contractions.
Age is between 18 - 99.

Who cannot join

Participants who refuse to sign an informed consent.
Participants with atrial fibrillation who are currently in a paced rhythm.

Trial locations and contacts

1 site in 1 country.

Lithuania1 site

Vilnius University
Vilnius

Other trials in Lithuania

About this study

A single center prospective case-control study to evaluate ability of a wearable to differentiate between atrial fibrillation (AF) and sinus rhythm (SR).

Conditions: Atrial Fibrillation
Being tested: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)
Keywords: wearable, electrocardiography, photoplethysmography
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)Device
Participants will use the wearable (the tested device) to record at least 2 minutes of photoplethysmography and 6-lead ECG. In addition, each subject will be monitored with synchronous ECG Holter monitoring (with eMotion Faros 90).

Study groups in NCT04281927
Study group	Role	What they receive
Atrial fibrillation		Patients with presumed atrial fibrillation will undergo monitoring with the device and Holter ECG. Receives: Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)
Sinus rhythm		Patients with presumed sinus rhythm will undergo monitoring with the device and Holter ECG. Receives: Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)
Sinus rhythm and frequent extrasystoles		Patients with presumed sinus rhythm and frequent extrasystoles will undergo monitoring with the device and Holter ECG. Receives: Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)

What is being measured

The primary outcome is the main question the study is designed to answer.

Diagnostic accuracy of a wearable system for atrial fibrillation detection
The wearable system comprises of two integrated components: a photoplethysmography (PPG) and a 6-lead ECG of the device. It works as described below.
First, an automatic PPG algorithm will indicate whether atrial fibrillation is suspected. The rhythm assessment of PPG algorithm is based on pulse regularity.
Next, a 6-lead ECG is acquired by the wearable. The rhythm assessment of ECG is based on P waves and regularity of QRS complexes. A diagnosis is made by independent cardiologists.
The conclusion of a whole system comprising of both described methods will be compared with a gold standard multi-lead Holter ECG. This standard ECG is also evaluated by independent cardiologists.
Measured: PPG will be assessed in 2 minutes. ECG will be assessed in up to 10 months.

Secondary outcomes (2)

Diagnostic accuracy of PPG algorithm of the wearable for atrial fibrillation detection
An automatic PPG algorithm will indicate whether atrial fibrillation is suspected. The rhythm assessment of PPG algorithm is based on pulse regularity. As a separate diagnostic tool it will be compared with a gold standard multi-lead Holter ECG which is assessed by independent cardiologists.
Measured: 2 minutes.
Diagnostic accuracy of a 6-lead ECG of the wearable for atrial fibrillation detection
Independent cardiologists will assess the heart rhythm in a 6-lead ECG acquired by the wearable. As a separate diagnostic tool it will be compared with a gold standard multi-lead Holter ECG which is also assessed by independent cardiologists. The rhythm evaluation of ECG is based on P waves and regularity of QRS complexes.
Measured: Up to 10 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 201915 Nov 2019

First posted24 Feb 2020
Study start6 Mar 2019
Primary completion15 Nov 2019
Study completion15 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
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: 435 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04281927
Sponsor's protocol ID: S-MIP-17-81
Acronym: DoubleCheckAF
Status last verified: Feb 2021
First submitted: 15 Jan 2020
Last updated: 10 Feb 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Wearable With Photoplethysmography and 6-lead Electrocardiography for Atrial Fibrillation Detection
ClinicalTrials.gov ID: NCT04281927
Acronym / sponsor ID: DoubleCheckAF / S-MIP-17-81
Conditions: Atrial Fibrillation
Keywords: wearable, electrocardiography, photoplethysmography
Study type: Observational
Recruitment status: Completed
Enrolment: 435 participants (actual)
Lead sponsor: Vilnius UniversityUniversity, hospital or other
Collaborators: Kaunas University of Technology
Study start: 6 Mar 2019 (actual)
Primary completion: 15 Nov 2019 (actual)
Study completion: 15 Nov 2019 (actual)
First posted: 24 Feb 2020 (actual)
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.

A single center prospective case-control study to evaluate ability of a wearable to differentiate between atrial fibrillation (AF) and sinus rhythm (SR).

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Atrial fibrillation	–	Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)Patients with presumed atrial fibrillation will undergo monitoring with the device and Holter ECG.
Sinus rhythm	–	Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)Patients with presumed sinus rhythm will undergo monitoring with the device and Holter ECG.
Sinus rhythm and frequent extrasystoles	–	Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)Patients with presumed sinus rhythm and frequent extrasystoles will undergo monitoring with the device and Holter ECG.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants of defined groups will be enrolled in Vilnius University Hospital Santaros Clinics.

Key inclusion criteria (2 listed)

Participants with current ECG-based diagnosis of atrial fibrillation, sinus rhythm or sinus rhythm with frequent (at least once in 2 minutes) premature atrial or ventricular contractions.
Age is between 18 - 99.

Key exclusion criteria (2 listed)

Participants who refuse to sign an informed consent.
Participants with atrial fibrillation who are currently in a paced rhythm.

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
Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)Participants will use the wearable (the tested device) to record at least 2 minutes of photoplethysmography and 6-lead ECG. In addition, each subject will be monitored with synchronous ECG Holter monitoring (with eMotion Faros 90).	Device	Atrial fibrillation, Sinus rhythm, Sinus rhythm and frequent extrasystoles

Primary outcome

Diagnostic accuracy of a wearable system for atrial fibrillation detection
Time frame: PPG will be assessed in 2 minutes. ECG will be assessed in up to 10 months.
The wearable system comprises of two integrated components: a photoplethysmography (PPG) and a 6-lead ECG of the device. It works as described below. First, an automatic PPG algorithm will indicate whether atrial fibrillation is suspected. The rhythm assessment of PPG algorithm is based on pulse regularity. Next, a 6-lead ECG is acquired by the wearable. The rhythm assessment of ECG is based on P waves and regularity of QRS complexes. A diagnosis is made by independent cardiologists. The conclusion of a whole system comprising of both described methods will be compared with a gold standard multi-lead Holter ECG. This standard ECG is also evaluated by independent cardiologists.

2 secondary outcomes

Diagnostic accuracy of PPG algorithm of the wearable for atrial fibrillation detection
Time frame: 2 minutes.
Diagnostic accuracy of a 6-lead ECG of the wearable for atrial fibrillation detection
Time frame: Up to 10 months.

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 10 Feb 2021.

Related trials for Atrial Fibrillation

Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
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.

Audrius Aidietis, Prof. PhD study chair

Vilnius University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Vilnius University at 1 site in Lithuania.

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 2 inclusion and 2 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lithuania. 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?

Diagnostic accuracy of a wearable system for atrial fibrillation detection (time frame: PPG will be assessed in 2 minutes. ECG will be assessed in up to 10 months.). 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 NCT04281927.

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 10 Feb 2021.