- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03274583
Mobile Phone Detection of Atrial Fibrillation (MODE-AF)
June 28, 2019 updated by: Juhani Airaksinen, University of Turku
The aim of this study is to evaluate the reliability of smartphone seismocardiographic detection of AF in comparison to the gold standard of continuous telemetry ECG recording.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In the this case-control study, 300 patients being treated in the wards of Heart Center and Department of Acute Internal Medicine of Turku University Hospital in Turku, Finland between April and September 2017 were included in the study.
Patients were assigned to two groups according to the prevalent heart rhythm (sinus rhythm or atrial fibrillation).
A smartphone equipped with an inbuilt accelerometer and a gyroscope was placed on the patient's chest to obtain a seismocardiographic recording.
Simultaneous telemetry electrocardiography was obtained to assess the reliability of seismographic rhythm recordings.
Results will be analyzed to describe the specificity and sensitivity of the method.
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Länsi-Suomen Lääni
-
Turku, Länsi-Suomen Lääni, Finland, 20521
- Turku University Hospital
-
-
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients treated in the wards of Heart Center and Acute Internal Medicine of Turku University Hospital, Turku Finland between April and September 2017.
Description
Inclusion Criteria for patients with FA:
- ≥18 years of age
- telemetry ECG available
- being treated in Turku University Hospital Heart Center / Acute internal medicine ward
- atrial fibrillation
Inclusion Criteria for patients with sinus rhythm:
- ≥18 years of age
- telemetry ECG available
- being treated in Turku University Hospital Heart Center / Acute internal medicine ward
- sinus rhythm
- gender and age matching pair in FA group
Exclusion Criteria:
- ≤18 years of age
- paced rhythm
- cardioversion during preceding 7 days
- informed consent not signed
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study Group
Patients being treated in the wards of Heart Center and Acute Internal Medicine of Turku University Hospital, Turku Finland between April and September 2017 with atrial fibrillation as the prevalent rhythm.
|
A short recording of heart rhythm using a smartphone.
|
Control group
Patients being treated in the wards of Heart Center and Acute Internal Medicine of Turku University Hospital, Turku Finland between April and September 2017 with sinus rhythm as the prevalent rhythm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sensitivity and specificity of seismocardiography in diagnosing atrial fibrillation
Time Frame: 2017-2018
|
2017-2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ACTUAL)
April 5, 2017
Primary Completion (ACTUAL)
October 1, 2017
Study Completion (ACTUAL)
November 1, 2017
Study Registration Dates
First Submitted
September 4, 2017
First Submitted That Met QC Criteria
September 4, 2017
First Posted (ACTUAL)
September 7, 2017
Study Record Updates
Last Update Posted (ACTUAL)
July 1, 2019
Last Update Submitted That Met QC Criteria
June 28, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- T02/005/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
-
Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
-
St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
-
R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
Clinical Trials on Smartphone seismographic recording
-
Poitiers University HospitalUniversity of PoitiersRecruitingAlzheimer Disease | Memory DisordersFrance
-
University of California, San FranciscoConquer Cancer FoundationActive, not recruitingProstate Cancer | Metastatic Prostate Cancer | Metastatic Castration-resistant Prostate CancerUnited States
-
Seoul National University HospitalKorea Advanced Institute of Science and TechnologyCompleted
-
Duke-NUS Graduate Medical SchoolSingHealth PolyclinicsUnknown
-
University of California, San FranciscoNot yet recruiting
-
University of UtahHuntsman Cancer InstituteTerminated
-
Centre d'Investigation Clinique et Technologique...National Research Agency, FranceCompletedAttitude to ComputersFrance
-
Guy's and St Thomas' NHS Foundation TrustUniversity of Oxford; Engineering and Physical Sciences Research Council, UKCompleted
-
NewPace LtdCompletedArrhythmias, Cardiac | TachyarrhythmiaUnited States
-
University of OklahomaWithdrawnRisk Reduction Behavior