Atrial FibrillationNCT04354506
Smart Phone Atrial Fibrillation Application
An observational study of Atrial Fibrillation, run by Institute of Longevity.
Trial summary
Patients with atrial fibrillation will have the chance to assess their disease management through an application available for free in Android and IOS smart devices Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 1 Jun 2022
- How long will I take part?
- 1 Year
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All eligible patients downloading specific AF mobile technology application
Who may be able to join
- Paroxysmal or persistent atrial fibrillation
Who cannot join
- unable to provide informed consent unable to have 1 year of follow-up for any reason
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessing Management of Patients With Atrial Fibrillation Through a Smart Phone Application
Patients with atrial fibrillation will have the chance to assess their disease management through an application available for free in Android and IOS smart devices
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, mobile technology
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation recurrence
Clinical episodes of atrial fibrillation, hospitalisation for atrial fibrillation
Measured: 1 year
Secondary outcomes (2)
Stroke incidence
Ischemic or hemorrhagic stroke
Measured: 1 year
Major bleeding incidence
GI bleeding, urinary bleeding necessitating hospitalisation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
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
- 5,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Institute of Longevity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitris Tsiachris, Institute of Longevity
- Investigators
- Dimitris Tsiachris, MD, PHD, Study chair, Institute of Longevity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354506
- Sponsor's protocol ID
- AFapp
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Management of Patients With Atrial Fibrillation Through a Smart Phone Application
- ClinicalTrials.gov ID
- NCT04354506
- Acronym / sponsor ID
- AFapp
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, mobile technology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Institute of LongevityUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 21 Apr 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.
Patients with atrial fibrillation will have the chance to assess their disease management through an application available for free in Android and IOS smart devices
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients downloading specific AF mobile technology application
Key inclusion criteria (1 listed)
- Paroxysmal or persistent atrial fibrillation
Key exclusion criteria (1 listed)
- unable to provide informed consent unable to have 1 year of follow-up for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Atrial fibrillation recurrence
Time frame: 1 year
Clinical episodes of atrial fibrillation, hospitalisation for atrial fibrillation
2 secondary outcomes
Stroke incidence
Time frame: 1 year
Major bleeding incidence
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Dimitris Tsiachris, MD, PHD study chair
Institute of Longevity
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Institute of Longevity.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dimitris Tsiachris, MD, PHD (+306944849926, dtsiachris@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation recurrence (time frame: 1 year). 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 21 Apr 2020.