Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)

Study Overview
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Brief Summary
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Patients with implantable cardioverter defibrillators (ICDs) should undergo regular device follow-ups every 3 months, to verify proper ICD function. However, many follow-ups are uneventful, revealing no relevant changes related to the implanted device and in the patient's diagnostic and therapeutic status. For time and economic reasons, longer follow-up intervals are frequently used although they are not according to recommendations. This may increase the delay in detection of relevant changes in the disease and in deviations from optimal ICD therapy in the individual patients. In the newest ICDs, the essential parameters reflecting safety and appropriateness of ICD therapy (threshold, impedance, intracardiac electrogram, etc.) are transmitted via Home Monitoring on a daily basis, to an internet platform accessible by the attending physician. In the present study, the investigators evaluate safety and efficacy of 12-month follow-up intervals in ICDs with Home Monitoring capability, as compared with conventional 3-month follow-up scheme.

Official Title
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Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)

Conditions
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Cardiac Pacing, Electric Countershock, Ventricular Tachyarrhythmia

Intervention / Treatment
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* Device: Implantable cardioverter defibrillator with Home Monitoring function
* Device: Standard implantable cardioverter defibrillator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for a single-chamber implantable cardioverter-defibrillator (ICD) Exclusion Criteria: Contraindication for ICD Indication for dual-chamber ICD or cardiac resynchronization therapy

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Home Monitoring | Device: Implantable cardioverter defibrillator with Home Monitoring function<br>* Implantable cardioverter defibrillators can send data from its diagnostic and therapy memory via wireless Home Monitoring on a daily basis to an internet based platform, securely accessed by the attending physician<br>* Other names: CardioMessenger (for Home Monitoring data transmission);|
| Active Comparator: 2<br>Home Monitoring not used | Device: Standard implantable cardioverter defibrillator<br>* Implantable cardioverter defibrillators used as standard devices without Home Monitoring<br>* Other names: Lumax 500/540 VR-T;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant adverse events, especially death, hospitalization, inadequate device therapies |  | 27 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 27 months | 
| Number of device follow-ups |  | 27 months | 
| Quality of life |  | 27 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implantable cardioverter defibrillator, Remote monitoring, Follow-up