REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor

Study Overview
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Brief Summary
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However, the current guidelines recommend the use of remote monitoring (RM) in patients with cardiac implantable electronic devices (CIED) to reduce inappropriate shocks or early detection of atrial fibrillation, data is incomprehensive on the effectiveness of decreasing heart failure events or mortality in patients with heart failure and reduced ejection fraction (HFrEF). The only randomized trial, which proved the efficacy of RM on mortality was the IN-TIME trial, which used a strict protocol for detection and intervention of the heart failure events. The primary aim of this study is to optimize the use of remote monitoring system in HFrEF patients already implanted an implantable cardiac defibrillator (ICD) or a cardiac resynchronization therapy (CRT). By creating a high-quality system with structured safety-net, which is able to use the data of remote monitoring messages and alerts of our patients, we can improve their outcome. The primary endpoint is the non-fatal heart failure event or all-cause mortality. Secondary outcomes include all-cause mortality, cardiovascular mortality, heart failure hospitalization, cardiovascular hospitalization, unscheduled visits, af burden, stroke, inappropriate shocks, quality of life, NYHA functional class. By using artificial intelligence-based methods, the optimal cut-off values of the previously, empirically used alert parameters will be validated or challenged. Additionally, cost-effectiveness to reduce the hospitalizations will be calculated. Due to this remote monitoring structured safety-net, these patients with severe heart failure can be treated more efficiently, safely and cost-effectively.

Official Title
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REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Remote monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CRT-P/CRT-D patients with a feasible device for home monitoring ICD (VVI/VDD/DDD) patients with a feasible device for home monitoring SR/AFib Transmission performance >80% in the first 2 weeks with new device Informed consent Exclusion Criteria: Life expectancy<1 year Unable to transmit data Patient is unable to visit the physician/clinic in 12 hours when it is indicated by the alerts Expected non-compliance Pregnancy Known drug, alcohol abuse Participation in other study or HM system concept

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Remote monitoring|Remote monitoring for patients with an ICD/CRT device|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite of all-cause mortality, heart failure events |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular mortality |  | 12 months | 
| cardiovascular hospitalization |  | 12 months | 
| unscheduled visits |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote monitoring, home monitoring, heart failure, cardiac resynchronization therapy, implantable cardioverter defibrillator