Atrial FibrillationDETECT AFNCT04375241
Detection of Asymptomatic Atrial Fibrillation in Persons of 65 Year of Age or Older
An observational study of Atrial Fibrillation, run by Diagram B.V. at 1 site in Netherlands.
Trial summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia. Although the condition itself is not life-threatening, the complications result in increased morbidity and mortality. AF is often asymptomatic and a considerable number of people suffering from AF are not aware of their condition. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device
- How many people
- 2,168 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Jul 2018to 30 Apr 2021
- How long will I take part?
- 1 Day
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The participants of this study will be subjects who visit their general practicioner or cardiologist or who visit the DETECT AF team at an event.
Who may be able to join
- Age ≥65 years
- Is willing to give informed consent
Who cannot join
- Known medical history with Atrial Fibrillation
- Not mental competent
Trial locations and contacts
1 site in 1 country.
About this study
Atrial fibrillation (AF) is the most common cardiac arrhythmia. Although the condition itself is not life-threatening, the complications result in increased morbidity and mortality. AF is often asymptomatic and a considerable number of people suffering from AF are not aware of their condition. Unfortunately, a cerebral infarction is often the first clinical manifestation. The idea to screen subjects opportunistically for Asymptomatic Atrial Fibrillation (AAF) was infeasible until recently. However, with a recently-developed smartphone connected Mobile ECG Device (MED), this seems to be feasible after all.
The main objectives are:
- To examine the feasibility of screening subjects of ≥65 years old for AAF.
- To validate the smartphone connected MED as an AAF screening instrument for application in transmural care in the Netherlands.
Read the detailed description
Study design:
Prospective validation study.
- Conditions
- Atrial Fibrillation
- Being tested
- Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device
- Keywords
- Mobile ECG device, Asymptomatic atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG DeviceOther
Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device
| Study group | Role | What they receive |
|---|---|---|
| Screening with Mobile ECG Device | Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device Receives: Other: Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the mobile ECG device
Measured: At screening
Specificity of the mobile ECG device
Measured: At screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start2 Jul 2018
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,168 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Diagram B.V.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375241
- Sponsor's protocol ID
- 9275
- Acronym
- DETECT AF
- Status last verified
- Jul 2022
- First submitted
- 1 May 2020
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not yet decided to share the individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Asymptomatic Atrial Fibrillation in Persons of 65 Year of Age or Older
- ClinicalTrials.gov ID
- NCT04375241
- Acronym / sponsor ID
- DETECT AF / 9275
- Conditions
- Atrial Fibrillation
- Keywords
- Mobile ECG device, Asymptomatic atrial fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,168 participants (actual)
- Lead sponsor
- Diagram B.V.University, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 5 May 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.
Atrial fibrillation (AF) is the most common cardiac arrhythmia. Although the condition itself is not life-threatening, the complications result in increased morbidity and mortality. AF is often asymptomatic and a considerable number of people suffering from AF are not aware of their condition. Unfortunately, a cerebral infarction is often the first clinical manifestation. The idea to screen subjects opportunistically for Asymptomatic Atrial Fibrillation (AAF) was infeasible until recently. However, with a recently-developed smartphone connected Mobile ECG Device (MED), this seems to be feasible after all.
The main objectives are:
- To examine the feasibility of screening subjects of ≥65 years old for AAF.
- To validate the smartphone connected MED as an AAF screening instrument for application in transmural care in the Netherlands.
Detailed description
Study design:
Prospective validation study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening with Mobile ECG Device | – | Other: Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG DeviceSubjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The participants of this study will be subjects who visit their general practicioner or cardiologist or who visit the DETECT AF team at an event.
Key inclusion criteria (2 listed)
- Age ≥65 years
- Is willing to give informed consent
Key exclusion criteria (2 listed)
- Known medical history with Atrial Fibrillation
- Not mental competent
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 |
|---|---|---|
| Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG DeviceSubjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device | Other | Screening with Mobile ECG Device |
Primary outcome
Sensitivity of the mobile ECG device
Time frame: At screening
Specificity of the mobile ECG device
Time frame: At screening
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 12 Jul 2022.
- Individual participant dataSharing planned: Undecided. We have not yet decided to share the individual participant data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diagram B.V. at 1 site in Netherlands.
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 12 Jul 2022. 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 Netherlands. 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?
Sensitivity of the mobile ECG device (time frame: At screening). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2022.