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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Adult patients with HF and no history of documented AF on electrocardiogram (ECG) are eligible.
Exclusion Criteria:
* Patients with CIED such as an implantable cardioverter defibrillator (ICD), Cardiac Resyn-chronization Therapy Defibrillator (CRT-D), or pacemaker.
* Documented AF before inclusion
* Admission to hospices or palliative care
* Inability to communicate in Dutch or English.
* Participant is under age of 18 years old
* Participant is pregnant
* Mental disorders that, according to the treating physician, make participation unsafe
Primary outcome measure(s)
Number of unplanned cardiac care utilization — 18 months 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.
Trial sites (1)
Facility
City
Region
Status
Medisch Spectrum Twente
Enschede
Netherlands
More Medisch Spectrum Twente trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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