An interventional study of Implantable loop recorder and Patient-driven portable ECG monitoring in Heart Failure, sponsored by Medisch Spectrum Twente. Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Medisch Spectrum Twente · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if using remote heart rhythm monitoring strategies can reduce unplanned cardiac care utilization and improve health-related quality of life 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) and do not have an existing pacemaker or implantable defibrillator.
The main questions the trial aims to answer are:
Researchers will compare two monitoring groups to a standard care group over an 18-month period to see which approach works best in heart failure treatment
Participants will:
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 266 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Medisch Spectrum Twente is the lead sponsor of 23 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 10, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm 1: Hospital-driven continuous rhythm monitoring with an implantable loop recorder (ILR) placed subcutaneously in the left pectoral region.
Device: Implantable loop recorder
Patient-driven single-lead portable ECG monitoring in which patients are instructed to send ECG recordings of at least 30 seconds both on a scheduled routine basis and whenever experiencing symptoms suggestive of an arrhytmia.
Device: Patient-driven portable ECG monitoring
All patients are treated according to the ESC guidelines (ESC HF 2026). This includes periodic outpatient utilization.
Other: Usual Care
Hospital-driven continuous monitoring with an implantable loop recorder
Patient-driven portable ECG monitoring
Usual care
Number of unplanned cardiac care utilization
Unplanned cardiac healthcare utilization will be assessed through systematic review of patients' medical records. The number of healthcare episodes occurring during the study observation period will be recorded. Each unique healthcare episode will be classified according to the principal setting of care: outpatient clinic, daycare/day-case admission, emergency care without admission, or hospitalization. Both total and stratified care utilization will be reported. An episode will be considered unplanned when healthcare is initiated in response to an acute, unexpected, worsening, or urgent cardiac health problem. Healthcare episodes involving transfers between care settings as part of the same continuous episode will be counted once and classified according to the highest level of care reached, to avoid double counting.
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 from inclusion to first diagnosis of AF
The clinical diagnosis of AF by a healthcare professional must be supported by ECG documentation demonstrating AF on a single-lead recording of at least 30 seconds or a standard 12-lead ECG, obtained using the assigned monitoring device or as part of routine clinical care.
Time frame: 18 months
The number of participants diagnosed with AF according to the electronic health rercords (EHR)
AF diagnosis will be established based on electrocardiographic (ECG) documentation obtained either through the assigned monitoring strategy or as part of routine clinical care, as assessed by a qualified healthcare professional.
Time frame: 18 months
Number of AF-related pharmacological and non-pharmacological management changes
Pharmacological changes include initiation, discontinuation, dose increase, dose decrease or switching of oral anticoagulants (OAC) and rate- and/or rhythm-control medications, including antiarrhythmic drugs. Non-pharmacological interventions include electrical or pharmacological cardioversion, catheter ablation and AF-related CIED implantation or reprogramming. The number of management changes will be grouped according to the treatment type and type of adjustment.
Time frame: 18 months
Number of HF-related pharmacological and non-pharmacological management changes during the study observation period.
Pharmacological changes include initiation, discontinuation, dose increase, dose decrease or switching of guideline-directed medical therapy (GDMT), including ARNI/ACEi/ARB, beta-blockers, mineralocorticoid receptor antagonists (MRA), sodium-glucose cotransporter-2 inhibitors (SGLT2i) and diuretics. Non-pharmacological interventions include HF-related CIED implantation or device reprogramming. The number of management changes will be grouped according to the treatment type and type of adjustment.
Time frame: 18 months
Number of overall arrhythmia diagnosis extracted from EHR
Number of overall arrhythmia diagnosis
Time frame: 18 months
Changes in Quality of life from baseline to 18 months follow-up as assessed by the Quality of life Kansas City Cardiomyopathy Questionnaire
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be collected at baseline and 18 months. The scores are represented on a scale from 0 to 100 points, where lower scores represent more severe symptoms and higher scores less or no symptoms.
Time frame: 18 months
Change in heart failure-related quality of life from baseline to 18-month follow-up, as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be collected at baseline and 18 months. The scores are represented on a scale from 0 to 100 points, where lower scores represent more severe symptoms and higher scores less or no symptoms.
Time frame: 18 months
Changes in overall Quality of Life from baseline to 18 months follow-up as assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L)
The EQ-5D-5L is a standardized questionnaire assessing health-related quality of life across five dimensions on a score from 1 to 5, with one no problems to a score of five with extreme problems on that domain. This allows for direct comparison between baseline and follow-up. The questionnaire also includes a visual analogue scale (EQ-VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health), on which participants rate their overall health. Furthermore, responses are used to calculate a health utility index score with values between 0 and 1. 0 indicates life valuation equal to death and one full health.
Time frame: 18 months
Mortality
Mortality
Time frame: 18 months
Plan to share: Yes
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Medisch Spectrum Twente