The goal of this clinical trial is to learn if using heart monitoring devices can lower unplanned hospital visits in adults with heart failure (HF). It focuses on adults with heart failure who have no history of an irregular heartbeat called atrial fibrillation (AF). The main questions the trial aims to answer are: Does a heart monitor placed under the skin lower unplanned hospital visits? Does a portable home device lower unplanned hospital visits? Researchers will compare these two groups to a standard care group to see which monitoring approach works best. Participants will: Answer a health survey at the start of the study and after 18 months. Have a small heart monitor placed under their chest skin to watch their heart rhythm, if they are in the first group. Use a handheld device to take weekly heart readings at home, if they are in the second group. Follow standard care from their regular doctor without any extra devices, if they are in the third group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
258
Hospital-driven continuous monitoring with an implantable loop recorder
Patient-driven portable ECG monitoring
Usual care
Medisch Spectrum Twente
Enschede, Netherlands
Number of unplanned cardiac care utilization
Number of unplanned cardiac care utilization. Healthcare utilization will be assessed as the number of healthcare episodes occurring during the study observation period. Each unique healthcare episode will be classified to the principal setting of care (hospitalization, emergency care, daycare/day case, or outpatient clinic). Healthcare episodes involving transfer from one setting to another will be counted according to the highest level of care reached, to avoid double counting. Unplanned healthcare utilization comprises unscheduled healthcare episodes initiated because of an acute, unexpected, worsening, or urgent health problem. This includes unplanned hospitalizations, emergency-care visits, and unplanned outpatient or urgent-care visits.
Time frame: 18 months
Number of planned cardiac care utilization
Planned healthcare utilization comprises healthcare episodes scheduled or arranged in advance for routine, preventive, diagnostic, therapeutic, monitoring, rehabilitation, or follow-up care. This includes planned hospitalizations, planned daycare/day-case encounters, and planned outpatient clinic visits.
Time frame: 18 months
Time to first diagnosis of AF
The clinical diagnosis of AF must be supported by ECG documentation showing a single-lead recording of 30 seconds or a standard 12-lead ECG, captured via the assigned monitoring de-vice or routine clinical care.
Time frame: 18 months
The number of participants diagnosed with AF
AF diagnosis will be based on ECG documentation obtained through the assigned monitoring strategy or routine clinical care
Time frame: 18 months
Pharmaceutical and/or CIED implantation management changes
Derived parameters will include the initiation/dose adjustment of oral anticoagulants (OAC), initiation of new rate/rhythm control medications to treat AF, performance of electrical/pharmacological cardioversion, or referral for catheter ablation.
Time frame: 18 months
Number of overall arrhythmia diagnosis
Number of overall arrhythmia diagnosis
Time frame: 18 months
Quality of life Kansas City Cardiomyopathy Questionnaire
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be collected at baseline and 18 months.
Time frame: 18 months
Mortality
Mortality
Time frame: 18 months
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