- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03509493
Detection of Atrial Fibrillation in Different Patient Target Groups Using the FibriCheck Smartphone Application
Detection of the Common Arrhythmia Atrial Fibrillation in Different Patient Target Groups Using the FibriCheck Smartphone Application
FibriCheck is a Conformité Européenne (CE)-approved (class IIa) medically diagnostic application that allows for heart rhythm registrations based on an optical signal captured via the smartphone camera. FibriCheck is only available on prescription causing the physician to stay in the 'driving seat' and the application distribution to be traced.
By using FibriCheck, a medically validated smartphone application, daily rhythm measurements can be performed using only the smartphone of the patient. This allows for the heart rhythm to be registered and monitored in a home environment and the data to be automatically sent to the physician. This enables the implementation of FibriCheck in two types of scenarios:
- Scenario 1: the follow-up of patients with high risk parameters for AF development for primary and secondary prevention, whereby detection of AF will result in therapeutic intervention
- Scenario 2: the realisation of monitoring of the heart rhythm of patients post intervention in a home environment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 50 million people in Europe and the U.S. It is associated with an increasing mortality and risk for transient cerebrovascular incidents and dementia. De novo AF is in most cases asymptomatic and paroxysmal, causing the diagnosis to be made either by chance or in response to an incident. This drastically impacts the quality of life of the patient and is accompanied with a high socio-economic cost. Guidelines indicate that anticoagulation in patients diagnosed with AF is a cost-effective solution for the prevention of strokes.
In addition, depending on the target group, patients identified with AF can receive therapy in order to control the heart rhythm. These procedures (cardioversion and ablation) often result in follow-up consultations that can be avoided if the heart rhythm can be monitored remotely.
By using FibriCheck, a medically validated smartphone application, daily rhythm measurements can be performed using only the smartphone of the patient. This allows for the heart rhythm to be registered and monitored in a home environment and the data to be automatically sent to the physician. This enables the implementation of FibriCheck in two types of scenarios:
- Scenario 1: the follow-up of patients with high risk parameters for AF development for primary and secondary prevention, whereby detection of AF will result in therapeutic intervention
- Scenario 2: the realisation of monitoring of the heart rhythm of patients post intervention in a home environment
The follow-up of patients is still driven by the treating physician(s). The objective is to implement a correct and successful process management allowing a smooth implementation of "an application on prescription".
Short- and long-term benefits the project wants to prove:
Short-term:
- AF can successfully be detected in a home environment using the FibriCheck application
Long-term: a successful detection of AF in a home environment can:
- Be the first step towards changing and improving the care pathway of the patient
- Induce therapeutic interventions in order to prevent strokes or other complications
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Limburg
-
Genk, Limburg, Belgium, 3600
- Ziekenhuis Oost Limburg
-
Hasselt, Limburg, Belgium, 3500
- Jessa Ziekenhuis
-
-
Oost-Vlaanderen
-
Gent, Oost-Vlaanderen, Belgium, 9000
- AZ Maria Middelares
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgium, 3000
- AC Huisartsengeneeskunde KU Leuven
-
-
West-Vlaanderen
-
Hooglede, West-Vlaanderen, Belgium, 8830
- HAK Hooglede
-
Ieper, West-Vlaanderen, Belgium, 8900
- Jan Yperman ziekenhuis
-
Kortrijk, West-Vlaanderen, Belgium, 8500
- AZ Groeninge
-
Roeselare, West-Vlaanderen, Belgium, 8800
- AZ Delta ziekenhuis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Group 1: Patients without structural heart disease
- Age 65 and older
- CHADSVASc score of 2 or more (including congestive heart failure, hypertension, age, diabetes, previous stroke, vascular disease and sex)
- Comorbidities such as: coronary artery disease, kidney insufficiency, sleep apnea or symptomatic complaints with negative Holter in the past
Group 2: Patients with structural heart disease
- Age 65 and older
- CHADSVASc score of 2 or more
- Left atrial volume indexed for body surface area (BSA) of 34 ml/m² or more, or left atrial diameter > 5 cm
And any of the following indicators:
- Diastolic dysfunction of at least grade 2 with restrictive filling (E/A 2 or more) or disturbed relaxation (E/A 0.8) and with E/e' septal 15 or more (E/e' lateral 10 or more) or tricuspid insufficiency (TI) of 2.8 m/s or more
- At least mitral insufficiency (grade 2/3 or 3/3) or mitral stenosis
- Hypertrophic (obstructive) cardiomyopathy
Group 3: Patients with high risk parameters for AF development
- Age 65 or more
- General Medical Record in the participating practice
- A 5-year risk of AF of at least 10% according to the CHARGE-AF risk score
Group 4: Patients post-cryptogenic stroke or TIA
- Experienced a cryptogenic TIA or stroke in the past year since the start of the study
Group 5: Patients post-cardioversion therapy
- Confirmed AF patient based on 12-lead ECG
- Successful AF treatment using cardioversion (DCC or chemical) to convert the heart rhythm back to normal sinus rhythm
- Subjects are older than 18 years
Group 6: Patients post-ablation therapy
- Confirmed AF patient based on 12-lead ECG
- Successful AF treatment using ablation therapy to restore the heart rhythm back to sinus rhythm in the past 3 months
- Subjects are older than 18 years
Exclusion Criteria:
- Non-native Dutch
- Pacemaker dependent heart rhythm
- Perniosis patient
- Intense callus formation
- Low adherence to protocol
- Tremor or Parkinson
- Signs of Alzheimer or dementia
- No self-care ability
- Known AF patient
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients without structural heart disease
|
Digital health application
|
Patients with structural heart disease
|
Digital health application
|
Patients with high risk parameters for AF development
|
Digital health application
|
Patients post-cryptogenic stroke
|
Digital health application
|
Patients post-cardioversion therapy
|
Digital health application
|
Patients post-ablation therapy
|
Digital health application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Detection of unknown atrial fibrillation
Time Frame: 31 December 2017
|
31 December 2017
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Detection of recurrent atrial fibrillation
Time Frame: 31 December 2017
|
31 December 2017
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 FibriCheck
-
Qompium NVCompletedAtrial FibrillationBelgium
-
Jessa HospitalRecruitingAtrial FibrillationBelgium
-
KU LeuvenQompium NVNot yet recruitingAtrial Fibrillation Paroxysmal
-
Qompium NVNot yet recruitingAtrial Fibrillation
-
Fundacio d'Investigacio en Atencio Primaria Jordi...Institut Català de la SalutRecruitingStroke | Atrial Fibrillation | Dementia | Atrial Fibrillation New OnsetSpain
-
Universitaire Ziekenhuizen KU LeuvenCompletedPostoperative Complications | Atrial Fibrillation | Arrhythmia | Atrial Fibrillation and FlutterBelgium
-
Ziekenhuis Oost-LimburgCompletedAtrial FibrillationBelgium
-
Ziekenhuis Oost-LimburgCompletedAtrial FibrillationBelgium