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
1 other identifier
observational
465
1 country
8
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedFirst Submitted
Initial submission to the registry
April 24, 2018
CompletedFirst Posted
Study publicly available on registry
April 26, 2018
CompletedApril 30, 2018
April 1, 2018
7 months
April 24, 2018
April 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection of unknown atrial fibrillation
31 December 2017
Secondary Outcomes (1)
Detection of recurrent atrial fibrillation
31 December 2017
Study Arms (6)
Patients without structural heart disease
Patients with structural heart disease
Patients with high risk parameters for AF development
Patients post-cryptogenic stroke
Patients post-cardioversion therapy
Patients post-ablation therapy
Interventions
Digital health application
Eligibility Criteria
All eligible patients are included in the corresponding group
You may qualify if:
- 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
- +11 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Qompium NVlead
Study Sites (8)
Ziekenhuis Oost Limburg
Genk, Limburg, 3600, Belgium
Jessa Ziekenhuis
Hasselt, Limburg, 3500, Belgium
AZ Maria Middelares
Ghent, Oost-Vlaanderen, 9000, Belgium
AC Huisartsengeneeskunde KU Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
HAK Hooglede
Hooglede, West-Vlaanderen, 8830, Belgium
Jan Yperman Ziekenhuis
Ieper, West-Vlaanderen, 8900, Belgium
AZ Groeninge
Kortrijk, West-Vlaanderen, 8500, Belgium
AZ Delta Ziekenhuis
Roeselare, West-Vlaanderen, 8800, Belgium
Related Publications (1)
Beerten SG, Proesmans T, Vaes B. A Heart Rate Monitoring App (FibriCheck) for Atrial Fibrillation in General Practice: Pilot Usability Study. JMIR Form Res. 2021 Apr 7;5(4):e24461. doi: 10.2196/24461.
PMID: 33825692DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2018
First Posted
April 26, 2018
Study Start
June 1, 2017
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
April 30, 2018
Record last verified: 2018-04