Low Workload Concept for the Detection of Silent Atrial Fibrillation (AF) and Atrial Fibrillation Burden in Patients at High Risk of AF and Stroke (CARE-DETECT)
Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring Wearable Cardiac Devices, Bed Sensor, Mobile Application, Rhythm Monitoring, Photoplethysmography, Accelerometer, Atrial Fibrillation Screening, Algorithm Development, Silent Atrial Fibrillation, Stroke, Mortality, Economic Evaluation
Eligibility Criteria
Inclusion Criteria:
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 but at least 24 hours before discharge to allow one day intervention in-hospital
- Age ≥18 years
- CHA2DS2VASC score ≥ 4, or CHA2DS2VASC score ≥ 2 and ECG P wave duration ≥120ms
- 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 Criteria:
- Age < 18 years
- Expected survival < 1 year
- Patient cannot be followed in the hospital at least 12 hours after randomization
- 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.
Sites / Locations
- Heart Center, Turku University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Interventional AF detection arm
Standard of care treatment arm
The patients will be monitored during index hospitalization according normal practice and additionally with a bed sensor, smartphone app, and patch-holter ECG. In addition, patients will have PDL monitoring device during hospitalization. During the index hospitalization, patients will download the CardioSignal app to their own smartphone or if patient does not have a smartphone one can be provided to the patient by the study group. Patients are asked to do the first recordings at hospital to test the device and then preferably twice daily for 1 minute period of time during the 3-month study period. When discharged home, the study subject will have the bed sensor for home-based use up to 3 months. If the average pulse rate in the bed sensor recordings have increased with 20% or the device has recorded rhythm irregularity lasting over 5 minutes (could be longer to reduce false alarms), a 12-lead ECG will be taken, and in the case of a normal ECG, a 7-day Holter monitoring is performed.
Patient will be followed as in routine clinical practice.