Status:
COMPLETED
Low Workload Concept for the Detection of Silent Atrial Fibrillation (AF) and Atrial Fibrillation Burden in Patients At High Risk of AF and Stroke
Lead Sponsor:
University of Turku
Collaborating Sponsors:
Philips Electronics Nederland BV
Everon Ltd
Conditions:
Atrial Fibrillation
Arrhythmias, Cardiac
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 inco...
Detailed Description
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,...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Age \< 18 years
- Expected survival \< 1 year
- Permanent anticoagulation therapy due to atrial fibrillation
- Patient lives outside the catchment area
- Any significant medical condition, which in the Investigator's opinion may interfere with the patient's optimal participation in the study.
Key Trial Info
Start Date :
April 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05351775
Start Date
April 12 2022
End Date
January 31 2025
Last Update
March 30 2025
Active Locations (1)
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1
Heart Center, Turku University Hospital
Turku, Finland, FI-20520