Benefits of Implantable Cardioverter Defibrillator Follow-up Using Remote Monitoring

Study Overview
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Brief Summary
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In many aspects of every-day life, modern communication systems bring about a remarkable increase in comfort and safety by transmitting data and information in an easy and reliable manner. In order to provide these advantages also to patients with implantable cardioverter-defibrillators, as well as to their physicians, BIOTRONIK has developed a long-distance implant telemetry to enable periodic trend and event-triggered transmissions of implant data and intracardiac electrogram over distances of several meters. The data is received by a patient device and subsequently automatically transferred to a BIOTRONIK Service Center that provides it to the physician on a password secured internet site. Hence, the physician receives diagnostic information without the patient having to visit the physician (Home Monitoring, HM). New possibilities will arise for a detailed medical and event-correlated supervision of the patient's therapy using electrically active implants.

Detailed Description
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State-of-the-art implantable cardioverter defibrillators (ICD) provide a variety of algorithms to optimize episode classification and to minimize the danger of delivering inadequate therapies. An important role in checking the correctness of episode detection, classification and treatment plays the intracardiac electrogram (IEGM), which is stored inside the ICD for every detected episode. However, to analyze the stored IEGM, the physician has to interrogate the implant, i.e. the patient has to visit the ICD ambulance for follow-up. As a result, follow-ups are performed principally to corroborate that the ICD has correctly classified and treated detected tachycardia episodes, to optimize the parameters and in case of adverse event detection, to modify the programmation. The extension of BIOTRONIK Home Monitoring® by IEGM-Online® with LUMOS ICD offers a new possibility to meet the following challenge: Due to its integrated long-distance telemetry, the implantable cardioverter defibrillator (ICD) LUMOS is capable of periodically transmitting data and IEGM-online from the ICD memory to the BIOTRONIK Service Center via patient device. The BIOTRONIK Service Center decodes the data and presents it to the physician on a password secured internet site. Additionally, in case certain event criteria are met, the most important Home Monitoring information is immediately faxed to the physician as an Event Report. These events can be customized by the physician. Thus, the physician will be able to closely monitor the patient and check the adequacy and efficiency of the ICD therapy without requiring the patient to visit the physician. The transmitted data comprise information on atrial and ventricular rhythm, atrioventricular conduction and system status. The purpose of the present study is to evaluate the safety and economic impact of ICD follow-up schedule with Home Monitoring in France. For this assessment, the investigation compares two groups: For the ACTIVE group, after a first follow-up, the patients are only followed by Home Monitoring and one follow-up per year. The ICD follow-up or therapeutic intervention will be primarily based and triggered on event reports reception and after cardio reports and IEGM-online analysis on internet site. The findings from this group will be compared to those of a group receiving standard of care (CONTROL group). Both patient groups will be followed for 27 months and will have Home Monitoring switched on. The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed. The clinical study will analyse, the incidence of significant serious adverse events (composite of all-cause mortality, cardiac and device related SAE), the costs reduction, the home-monitoring workload, the quality of life, the incremental Costs/Effectiveness ratio, the patient willing-to-pay, the delay of Home Monitoring to manage adverse events, the sensitivity of Home Monitoring to detect ICD dysfunctions, the inappropriate therapies rate and impact on hospitalization, the number of ICD charge and impact on battery longevity. The trial will be conducted as a prospective, randomized, open, multicenter, national clinical trial. The enrolment of 400 patients in 40 clinical centres in France is anticipated

Official Title
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Effectiveness and Cost Of ICD Follow-up Schedule With Telecardiology

Conditions
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Implantable Cardioverter-Defibrillators, Ventricular Fibrillation, Tachycardia, Ventricular

Intervention / Treatment
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* Other: ACTIVATION of HOME MONITORING


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for single or dual chamber ICD Exclusion Criteria: NYHA class IV Pregnant woman or woman who plan to become pregnant during the trial Patient whose medical situation is not stable Presence of any disease, other than patient's cardiac disease, associated with reduced likelihood of survival for the duration of the trial, e.g. cancer, uraemia (urea > 70mg/dl or creatinine >3mg/dl), liver failure, etc. Age < 18 years Patient unable to handle Home Monitoring system correctly The patient is not willing and able to comply with the protocol Change of residence expected during study Insufficient GSM coverage at patient's home Participation in another clinical study Patient unwilling to sign the consent for participation.

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CONTROL Group - Without Home Monitoring<br>Patients receiving the standard of care. Due to safety concerns, the patients are followed every 6 months after a first follow-up, which is performed between 1 and 3 months after implantation. | Other: ACTIVATION of HOME MONITORING<br>* Both patient groups will be followed for 27 months and will have Home Monitoring switched on. The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed.<br>|
| Experimental: ACTIVE GROUP With Home Monitoring<br>After a first follow-up (between 1 and 3 months after implantation), the patients are followed one time per year. Within this period, the additional ICD follow-up or therapeutic intervention will be primarily triggered on cardio-reports reception, Data/IEGM-online analysis on internet site or patient/physician call. | Other: ACTIVATION of HOME MONITORING<br>* Both patient groups will be followed for 27 months and will have Home Monitoring switched on. The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with more than one Significant Serious Adverse Event (SSAE) since home-monitoring activation. SSAE is a composite comprising all-cause mortality, cardiac or device related Serious Adverse Events |  | 27 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total costs minimization analyse |  | 27 months | 
| Delay of Home Monitoring to manage adverse events |  | 27 months | 
| Sensitivity of Home Monitoring to detect ICD dysfunction |  | 27 months | 
| Number of capacitor charge and incidence on ICD-battery longevity |  | 27 months | 
| Difference of cardiac and device related Adverse Event |  | 27 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home monitoring, Remote monitoring, Defibrillators, Implantable, Shock, Implantable cardioverter-defibrillator Therapy