ClinicalTrials.gov
ClinicalTrials.gov Menu

Detection of Atrial Fibrillation in Different Patient Target Groups Using the FibriCheck Smartphone Application

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03509493
Recruitment Status : Completed
First Posted : April 26, 2018
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Qompium NV

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

Condition or disease Intervention/treatment
Atrial Fibrillation Diagnostic Test: FibriCheck

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 : Observational
Actual Enrollment : 465 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of the Common Arrhythmia Atrial Fibrillation in Different Patient Target Groups Using the FibriCheck Smartphone Application
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients without structural heart disease Diagnostic Test: FibriCheck
Digital health application

Patients with structural heart disease Diagnostic Test: FibriCheck
Digital health application

Patients with high risk parameters for AF development Diagnostic Test: FibriCheck
Digital health application

Patients post-cryptogenic stroke Diagnostic Test: FibriCheck
Digital health application

Patients post-cardioversion therapy Diagnostic Test: FibriCheck
Digital health application

Patients post-ablation therapy Diagnostic Test: FibriCheck
Digital health application




Primary Outcome Measures :
  1. Detection of unknown atrial fibrillation [ Time Frame: 31 December 2017 ]

Secondary Outcome Measures :
  1. Detection of recurrent atrial fibrillation [ Time Frame: 31 December 2017 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All eligible patients are included in the corresponding group
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509493


Locations
Belgium
Ziekenhuis Oost Limburg
Genk, Limburg, Belgium, 3600
Jessa Ziekenhuis
Hasselt, Limburg, Belgium, 3500
AZ Maria Middelares
Gent, Oost-Vlaanderen, Belgium, 9000
AC Huisartsengeneeskunde KU Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
HAK Hooglede
Hooglede, West-Vlaanderen, Belgium, 8830
Jan Yperman Ziekenhuis
Ieper, West-Vlaanderen, Belgium, 8900
AZ Groeninge
Kortrijk, West-Vlaanderen, Belgium, 8500
AZ Delta Ziekenhuis
Roeselare, West-Vlaanderen, Belgium, 8800
Sponsors and Collaborators
Qompium NV

Responsible Party: Qompium NV
ClinicalTrials.gov Identifier: NCT03509493     History of Changes
Other Study ID Numbers: 1
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Qompium NV:
Primary prevention
Secondary prevention
Clinical practice

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes