Interactive Patient's Assistant - LUCY

Study Overview
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Brief Summary
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Patients with chronic heart failure (CHF) and reduced left ventricle ejection fraction benefit from cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD). Currently used devices, besides delivering low and high-energy therapies, record patient's activity and many hemodynamic parameters. However, increasing numbers of patient with CRT and ICD devices produce overload of cardiology centers where patients are admitted to ambulatory visits. Contrarily, there are technological possibilities for remote monitoring proven to be effective in recognizing damage of the implanted device and risk of exacerbation of chronic heart failure. Patients' registries show that majority of ambulatory visits are unproductive and do not result in significant modification of device's parameters. Promising experiences with application of data mining and machine learning techniques allow us to assume probable benefits from using modern methods of data analysis in determination of requirement for ambulatory follow-up on basis of data gathered through telemonitoring and clinical assessment of a patient. Aim of the study is to find multivariate model predicting the requirement for ambulatory follow-up of IECD.

Official Title
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Interactive Patient's Assistant to Optimize Long-term Care in Patients With Chronic Health Failure and Determine Which Parameters of CIED Indicate the Requirement for Ambulatory Follow-up

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Diagnostic Test: Multivariate assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-90 years old Chronic heart failure (NYHA class I to III) Implanted ICD or CRT (at least 30 days before inclusion)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CHF and CIED patients<br>600 CHF patients with ICD or CRT admitted to regulatory ambulatory visit. | Diagnostic Test: Multivariate assessment<br>* Patient's status assessment according to clinical evaluation and data acquired from the implanted device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory visit qualified as meaningful due to change in pharmacotherapy or ICD parameters related to tachycardia detection or treatment. | Primary outcome is composed of: any change in pharmacotherapy (modification of agents or doses) related to patient's clinical status assessed during the visit, any change in tachyarrythmia counter or discriminator status, any change in tachyarrythmia threshold, ventricular undersensing or oversensing. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory visit qualified as meaningful due to alarming condition related to ICD. | Secondary outcome is composed of: sustained or treated ventricular tachyarrythmia, any not previously diagnosed supraventricular tachyarrythmia, elective replacement indicator, atrial undersensing or oversensing, atrial or ventricular ineffective pacing. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac implantable electronic device, Cardiac resynchronization therapy, Implantable cardioverter-defibrillator, Machine learning, Mobile application, Patient's assistance