INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored Implanted Cardioverter Defibrillators (ICD) SysTems

Study Overview
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Brief Summary
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It's the aim of this study to analyze the benefit of personal patient / physician contacts in heart failure patients with remotely monitored implanted cardioverter defibrillators (ICD) or ICD with cardiac resynchronization therapy (CRT-D). The personal follow up (in clinic or phone calls) will be compared to completely automatic remote follow ups. All patients will receive remote monitoring for automatic daily alarm checks and will undergo in clinic follow ups in 12 months intervals

Official Title
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INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored ICD SysTems

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Quarterly remote follow ups and remote monitoring
* Other: Quarterly remote follow ups + additional phone calls and remote monitoring
* Other: Quarterly in clinic follow ups and remote monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for implantation (new, boxchange, upgrade) of ICD/ CRT-D Written informed consent Ejection Fraction <= 35% New York Heart Association (NYHA) Class I-III Age >=18 and <=80 years In patient's home environment sufficient infrastructure (analog phone line or sufficient strength of GSM (Global System for Mobile communication) mobile phone network) for running a Merlin@home transmitter is available Exclusion Criteria: Arterio ventricular (AV) Block III / AV Block II Type Mobitz Severe renal insufficiency Coronary angiology intervention within previous 3 months Myocardial infarction within previous month Life expectancy < 1 year Expected poor data quality / compliance Pregnancy Patient is already participating to another study with active therapy arm

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 |
| --- | --- |
| Active Comparator: Group A<br>Automatic anonymous ICD/CRTD follow up (quarterly remote follow ups) | Other: Quarterly remote follow ups and remote monitoring<br>* Quarterly remote follow ups and remote monitoring<br>|
| Active Comparator: Group B1<br>Personal ICD/CRTD follow up (phone calls + quarterly remote follow ups) | Other: Quarterly remote follow ups + additional phone calls and remote monitoring<br>* Quarterly remote follow ups + additional phone calls and remote monitoring<br>|
| Active Comparator: Group B2<br>Personal ICD/CRTD follow up (Quarterly visits) | Other: Quarterly in clinic follow ups and remote monitoring<br>* Quarterly in clinic follow ups and remote monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of patients with worsened outcome in reference to Packer's Heart Failure Clinical Composite Response |  | 12 months (between 1 and 13 months post implant) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 12 months (between 1 and 13 months post implant) | 
| Heart failure hospitalizations |  | 12 months (between 1 and 13 months post implant) | 
| Cardiovascular events |  | 12 months (between 1 and 13 months post implant) | 
| Number of additional, unscheduled follow ups |  | 12 months (between 1 and 13 months post implant) | 
| Number of follow ups with relevant findings |  | 12 months (between 1 and 13 months post implant) | 
| Number of delivered / appropriate ICD therapies |  | 12 months (between 1 and 13 months post implant) | 
| Quality of life (MLHFQ) |  | 12 months (between 1 and 13 months post implant) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD, CRTD, Remote care, Remote monitoring, Heart failure