- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04354506
Smart Phone Atrial Fibrillation Application
April 17, 2020 updated by: Dimitris Tsiachris, Institute of Longevity
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
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dimitris Tsiachris, MD, PHD
- Phone Number: +306944849926
- Email: dtsiachris@yahoo.com
Study Contact Backup
- Name: Athanasios Kordalis, MD, PHD
- Phone Number: 6972225950
- Email: akordalis@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All eligible patients downloading specific AF mobile technology application
Description
Inclusion Criteria:
Paroxysmal or persistent atrial fibrillation
Exclusion Criteria:
unable to provide informed consent unable to have 1 year of follow-up for any reason
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Atrial fibrillation recurrence
Time Frame: 1 year
|
Clinical episodes of atrial fibrillation, hospitalisation for atrial fibrillation
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroke incidence
Time Frame: 1 year
|
Ischemic or hemorrhagic stroke
|
1 year
|
Major bleeding incidence
Time Frame: 1 year
|
GI bleeding, urinary bleeding necessitating hospitalisation
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Dimitris Tsiachris, MD, PHD, Institute of Longevity
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2020
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
April 17, 2020
First Submitted That Met QC Criteria
April 17, 2020
First Posted (Actual)
April 21, 2020
Study Record Updates
Last Update Posted (Actual)
April 21, 2020
Last Update Submitted That Met QC Criteria
April 17, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFapp
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
-
Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
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Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
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AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
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Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
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Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
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Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
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Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
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Beijing Anzhen HospitalJohnson & Johnson; Heart Health Research CenterNot yet recruitingParoxysmal Atrial Fibrillation | Persistent Atrial Fibrillation
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Maastricht UniversityRadboud University Medical Center; Maastricht University Medical CenterRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Atrial Fibrillation ParoxysmalNetherlands