NCT05351775Completed
Low Workload Concept for the Detection of Silent Atrial Fibrillation (AF) and Atrial Fibrillation Burden in Patients At High Risk of AF and Stroke
Cardiovascular Research Consortium - a Randomized Prospective Trial to Assess Low Workload Concept for the Detection of Silent Atrial Fibrillation (AF) and Atrial Fibrillation Burden in Patients At High Risk of AF and Stroke
Source: ClinicalTrials.gov · Last updated 30 Mar 2025
Brief summary (registry, in English)
Patient-centered novel e-health technology and services will lay the foundation for future healthcare systems and services to support health and welfare promotion. Yet, there is a lack of ways to incorporate novel technological innovations into easy-to-use, cost-effective and low workload treatment. The detection of atrial fibrillation (AF) paroxysms and its permanent form as well as the prevention of AF-related strokes are major challenges in cardiology today. AF is often silent or asymptomatic, but the risk of ischemic stroke seems to be similar regardless of the presence or absence of symptoms. CARE-DETECT algorithm development part I will investigate following topics: 1. The usefulness and validity of bed sensor and mobile phone application in rhythm disorder capture compared to gold standard ECG-holter monitoring (Faros ECG) 2. Accuracy of AF detection from PDL data 3. Technical development of algorithms to detect arrhythmia from data collected with these novel devices 4. Development of a pre-processing tool that will evaluate the collected data and generate a preliminary filtered report of the raw data to ease clinician's workload in data handling and rhythm evaluation. CARE-DETECT clinical trial (part II) proposal provides a new concept for low workload for healthcare personnel, high diagnostic yield in silent AF detection and AF burden evaluation. CARE-DETECT protocol proposal seeks to address following issues: 1. Can a combination of actively used smartphone application and passive monitoring with bed sensor (with upstream ECG) - compared to routine care - enhance the detection of AF in patients who are at increased risk of stroke and have undergone a cardiac procedure? 2. What is the actual AF burden in paroxysmal AF patients after the detection of new-onset AF? 3. Can a direct-to-consumer telehealth with integrated cloud-based telecardiology service for medical professionals improve the efficacy of silent AF detection and what is the AF burden in patients suffering of (asymptomatic) paroxysmal AF and secondarily what is the cost-effectiveness of these new screening methods? 4. Additionally, during the hospitalization phase of the study part II PDL data will be collected in the intervention group. PDL data will be analyzed offline with the purpose to develop new methods and will not be used to monitor treatment or for diagnosis.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 12 Apr 2022
- Start date
- 12 Apr 2022
- Primary completion date
- 23 Apr 2024
- Lead sponsor
- University of Turku
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT05351775
What you commit to
- Study type: Interventional
- Participants enrolled: 150
- From 12 Apr 2022 to the primary completion date, 23 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Permanent anticoagulation therapy due to atrial fibrillation
Other illness
- Any significant medical condition, which in the Investigator's opinion may interfere with the patient's optimal participation in the study.
Age
- Age \< 18 years
Other
- Expected survival \< 1 year
- Patient lives outside the catchment area
Who the study is looking for
- One of listed cardiac operation performed during the index hospitalization:
- open heart surgery (aortic valve replacement (AVR), coronary artery bypass graft (CABG) or combination treatment) or
- percutaneous intervention (transcatheter aortic valve implantation (TAVI) or percutaneous coronary intervention (PCI))
- Patient has been informed on the nature of the study, agrees to its provisions and has provided written informed consent approved by the appropriate Medical Ethics committee.
- In PCI group, the randomization may take place after operation
- Age ≥18 years
- CHA2DS2VASC score ≥ 4, or CHA2DS2VASC score ≥ 2 and at least one of the following: ECG P wave duration ≥ 120 ms, left atrial diameter \> 38 mm in women or \> 40 mm in men, renal impairment (eGFR \< 50 ml/min), age ≥ 70 years, active smoking
- Anticipated life expectancy 12 months or more
- Patient is capable of using the study application and bed sensor
- Patient is willing to comply with study specific follow-up evaluations and home-based monitoring
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Heart Center, Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Unknown status |
Related publications
- Randomized trial of smartphone application and bed sensor for atrial fibrillation detection in high-risk patients.Sci Rep · 2026 · PMID 41634330
This page is information, not medical advice. Discuss any trial with your doctor.