[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650554":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":23,"locations":29,"responsibleParty":50,"collaborators":52,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":10,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Seerlinq s. r. o.","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Documented AF",null,"HF patients with a history of permanent\u002Fparoxysmal AF and AF documented on 12-lead ECG at enrollment",[13],"Other: PPG-based AF detection algorithm",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-AF","HF patients in sinus rhythm on the index 12-lead ECG with no prior documented AF episodes",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"PPG-based AF detection algorithm","The PPG-based atrial fibrillation detection algorithm is a non-invasive signal processing approach that analyzes photoplethysmographic waveforms obtained during remote monitoring. The algorithm evaluates pulse-to-pulse variability, waveform characteristics, and signal quality parameters to identify irregular rhythm patterns associated with atrial fibrillation and provide early detection of potential arrhythmic events.",[9,15],[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Marta Kollárová, MSc., PhD.","CONTACT","+421 950 896 026","marta.kollarova@premedix.org",[30],{"facility":31,"status":32,"city":33,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Premedix","RECRUITING","Bratislava","Slovakia","SK",{"type":37,"coordinates":38},"Point",[39,40],17.10674,48.14816,{"lat":40,"lon":39},[43,47],{"name":44,"role":26,"phone":45,"phoneExt":10,"email":46},"Allan Bohm, M.D., MSc. PhD.","+421 907 411 499","allan.bohm@premedix.org",{"name":48,"role":49,"phone":10,"phoneExt":10,"email":10},"Allan Bohm, M.D., MSc., PhD.","PRINCIPAL_INVESTIGATOR",{"type":51,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[53,56],{"name":54,"class":55},"ACADEMY - občianske združenie","UNKNOWN",{"name":57,"class":6},"Premedix Academy","100650554","a-photoplethysmography-based-machine-learning-algorithm-for-early-atrial-fibrillation-detection-a-prospective-validation-study-100650554",false,"NCT07749183","A Photoplethysmography-Based Machine Learning Algorithm for Early Atrial Fibrillation Detection: A Prospective Validation Study","Prospective Validation of a Machine-Learning Algorithm Using Photoplethysmography Signals for Early Detection of Atrial Fibrillation During Remote Telemonitoring","HeartCore AF","Inclusion Criteria:\n\n* Adults ≥18 years with a diagnosis of heart failure (HFrEF, HFmrEF, or HFpEF)\n* 12-lead ECG performed to confirm cardiac rhythm classification (AF vs. non-AF)\n\nExclusion Criteria:\n\n* Missing a valid PPG recording","ALL","18 Years",{"count":69,"type":70},200,"ESTIMATED","OBSERVATIONAL","This is a prospective study validating a new machine-learning algorithm that detects atrial fibrillation (AF) from photoplethysmography (PPG) signals, developed for integration into the Seerlinq remote monitoring platform. This algorithm builds on the same core PPG signal-processing technology as Seerlinq's HeartCore device, a CE-certified (Class IIb, MDR) device that monitors left ventricular filling pressures in heart failure patients. The algorithm will be validated through internal cross-validation, external validation against an independent cohort with paired PPG-ECG recordings, and validation in a cohort of patients with paroxysmal atrial fibrillation and frequent sinus-AF transitions.",[74,75],"Atrial Fibrillation (AF)","Heart Failure",[77,78,79,80,81,82],"Photoplethysmography","Machine learning","Remote telemonitoring","Wearable device","Digital biomarker","Arrhythmia detection","2026-07-31",{"date":85,"type":86},"2026-08-06","ACTUAL",{"date":88,"type":86},"2025-10-01",{"date":90,"type":70},"2026-11",{"name":5,"class":6},1]