Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients

Study Overview
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Brief Summary
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The purpose of this study is to investigate the cost-effectiveness and effectiveness of remote-monitoring compared to standard care in patients with implantable cardioverter defibrillator.

Detailed Description
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Implantable cardioverter defibrillator (ICD) are an important and effective treatment in patients at risk of sudden cardiac death. In order to allow for a more continuous follow-up and reduced complication rates of patients with ICD, new devices including remote-monitoring (home-monitoring) features of patients with ICD have been developed. BIOTRONIK Home Monitoring service enables the doctors to safely follow up their patients with implanted cardioverter-defibrillators in a remote fashion, with fewer in-clinic consultations. This may result in a more efficient follow-up and cost-savings for the health care payer. The objective of the current study is to investigate the cost-effectiveness and effectiveness of home-monitoring compared to standard care.

Official Title
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Home-Monitoring in ICD Patients

Conditions
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Ventricular Arrythmias

Intervention / Treatment
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* Device: Home-monitoring provided by LUMAX ICD device and CardioMessenger II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is willing/able to undergo the study protocol appointments and procedures/questionnaires Indication for implantation of single chamber ICD or dual chamber ICD according to European guidelines Exclusion Criteria: Age < 18 and > 80 years Expected non-compliance Known drug or alcohol abuse Life expectancy < 1 year NYHA classification IV Participation in another clinical study Participation in another telemonitoring concept Pregnant or breast-feeding woman Uncontrolled hypertension No mobile phone use possible in patient residence

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-monitoring<br>Patients receive an additional home-monitoring (remote-monitoring) device (CardioMessengerII) following Biotronik Lumax ICD implantation. The device enables regular transmission and examination of ICD information via home-monitoring. Follow-up appointments in outpatient clinic are changed compared to standard care. While follow-up 1, 12, and 24 months after ICD implantation consist of outpatient clinic appointments, follow-up 3, 6, and 18 months after ICD implantation are conducted remotely. | Device: Home-monitoring provided by LUMAX ICD device and CardioMessenger II<br>* All study participants receive an ICD of the Biotronik lumax family. Only participants of the intervention group receive the CardioMessengerII to allow for transmission of regular home monitoring messages. All study participants will be followed for 12 to 24 months (depending on the time of recruitment). The intervention and comparison to be investigated is home-monitoring vs. no home-monitoring. The intervention involves a combination of in-clinic consultations and regular use of home-monitoring services. As part of the modified follow-up schedule of intervention patients compared to standard care, follow-up in-clinic consultations 3, 6, and 18 months after ICD implantation will be replaced by home-monitoring follow-up.<br>* Other names: CardioMessenger;|
| No Intervention: Standard care<br>Patients randomised to the standard care group receive no home-monitoring device (CardioMessengerII) following Lumax ICD implantation. Patients have scheduled follow-up appointments at the ICD outpatient clinics at 1, 3, 6, 12, 18, and 24 months after ICD implantation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of disease specific costs from a societal perspective. |  | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of shocks |  | up to 24 months | 
| Hospital admissions |  | up to 24 months | 
| Cardiac events |  | up to 24 months | 
| Quality of life |  | up to 24 months | 
| Disease specific Costs from third party payers perspective |  | up 24 months | 
| Overall costs from societal and third party payers perspective |  | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients with ventricular arrhythmias and the prevention of sudden cardiac death