Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT03509493
Status:
COMPLETED
Last Update Posted:
2018-04-30
First Post:
2018-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Atrial Fibrillation in Different Patient Target Groups Using the FibriCheck Smartphone Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 465}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-26', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-04-24', 'lastUpdatePostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of unknown atrial fibrillation', 'timeFrame': '31 December 2017'}], 'secondaryOutcomes': [{'measure': 'Detection of recurrent atrial fibrillation', 'timeFrame': '31 December 2017'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary prevention', 'Secondary prevention', 'Clinical practice'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '33825692', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nBy 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:\n\n* 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\n* Scenario 2: the realisation of monitoring of the heart rhythm of patients post intervention in a home environment", 'detailedDescription': '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.\n\nIn 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.\n\nBy 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:\n\n* 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\n* Scenario 2: the realisation of monitoring of the heart rhythm of patients post intervention in a home environment\n\nThe 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".\n\nShort- and long-term benefits the project wants to prove:\n\nShort-term:\n\n\\- AF can successfully be detected in a home environment using the FibriCheck application\n\nLong-term: a successful detection of AF in a home environment can:\n\n* Be the first step towards changing and improving the care pathway of the patient\n* Induce therapeutic interventions in order to prevent strokes or other complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All eligible patients are included in the corresponding group', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nGroup 1: Patients without structural heart disease\n\n* Age 65 and older\n* CHADSVASc score of 2 or more (including congestive heart failure, hypertension, age, diabetes, previous stroke, vascular disease and sex)\n* Comorbidities such as: coronary artery disease, kidney insufficiency, sleep apnea or symptomatic complaints with negative Holter in the past\n\nGroup 2: Patients with structural heart disease\n\n* Age 65 and older\n* CHADSVASc score of 2 or more\n* Left atrial volume indexed for body surface area (BSA) of 34 ml/m² or more, or left atrial diameter \\> 5 cm\n* And any of the following indicators:\n\n * 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\n * At least mitral insufficiency (grade 2/3 or 3/3) or mitral stenosis\n * Hypertrophic (obstructive) cardiomyopathy\n\nGroup 3: Patients with high risk parameters for AF development\n\n* Age 65 or more\n* General Medical Record in the participating practice\n* A 5-year risk of AF of at least 10% according to the CHARGE-AF risk score\n\nGroup 4: Patients post-cryptogenic stroke or TIA\n\n\\- Experienced a cryptogenic TIA or stroke in the past year since the start of the study\n\nGroup 5: Patients post-cardioversion therapy\n\n* Confirmed AF patient based on 12-lead ECG\n* Successful AF treatment using cardioversion (DCC or chemical) to convert the heart rhythm back to normal sinus rhythm\n* Subjects are older than 18 years\n\nGroup 6: Patients post-ablation therapy\n\n* Confirmed AF patient based on 12-lead ECG\n* Successful AF treatment using ablation therapy to restore the heart rhythm back to sinus rhythm in the past 3 months\n* Subjects are older than 18 years\n\nExclusion Criteria:\n\n* Non-native Dutch\n* Pacemaker dependent heart rhythm\n* Perniosis patient\n* Intense callus formation\n* Low adherence to protocol\n* Tremor or Parkinson\n* Signs of Alzheimer or dementia\n* No self-care ability\n* Known AF patient"}, 'identificationModule': {'nctId': 'NCT03509493', 'briefTitle': 'Detection of Atrial Fibrillation in Different Patient Target Groups Using the FibriCheck Smartphone Application', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qompium NV'}, 'officialTitle': 'Detection of the Common Arrhythmia Atrial Fibrillation in Different Patient Target Groups Using the FibriCheck Smartphone Application', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients without structural heart disease', 'interventionNames': ['Diagnostic Test: FibriCheck']}, {'label': 'Patients with structural heart disease', 'interventionNames': ['Diagnostic Test: FibriCheck']}, {'label': 'Patients with high risk parameters for AF development', 'interventionNames': ['Diagnostic Test: FibriCheck']}, {'label': 'Patients post-cryptogenic stroke', 'interventionNames': ['Diagnostic Test: FibriCheck']}, {'label': 'Patients post-cardioversion therapy', 'interventionNames': ['Diagnostic Test: FibriCheck']}, {'label': 'Patients post-ablation therapy', 'interventionNames': ['Diagnostic Test: FibriCheck']}], 'interventions': [{'name': 'FibriCheck', 'type': 'DIAGNOSTIC_TEST', 'description': 'Digital health application', 'armGroupLabels': ['Patients post-ablation therapy', 'Patients post-cardioversion therapy', 'Patients post-cryptogenic stroke', 'Patients with high risk parameters for AF development', 'Patients with structural heart disease', 'Patients without structural heart disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '3500', 'city': 'Hasselt', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '9000', 'city': 'Ghent', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'AZ Maria Middelares', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'AC Huisartsengeneeskunde KU Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '8830', 'city': 'Hooglede', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'HAK Hooglede', 'geoPoint': {'lat': 50.98333, 'lon': 3.08333}}, {'zip': '8900', 'city': 'Ieper', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Jan Yperman Ziekenhuis', 'geoPoint': {'lat': 50.85114, 'lon': 2.88569}}, {'zip': '8500', 'city': 'Kortrijk', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'AZ Groeninge', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '8800', 'city': 'Roeselare', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'AZ Delta Ziekenhuis', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qompium NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}