PAtient NOtifier Feature for Reduction of Anxiety

Study Overview
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Brief Summary
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This study is intended to look at the effect of the SJM vibrating Patient Notifier™ system, which will warn the patient of possible failures of the implanted system, on reducing patient device related anxiety

Official Title
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PAtient NOtifier Feature for Reduction of Anxiety: A Multicenter ICD Study

Conditions
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Tachycardia, Ventricular

Intervention / Treatment
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* Device: ICD implant + Patient Notifier turned OFF
* Procedure: ICD Implant + Patient Notifier turned ON


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has recently (min. 2 weeks - max. 14 weeks) been implanted with an SJM ICD with the Patient Notifier™ feature; Patient is willing and able to independently comprehend and complete the study-related questionnaires; Patient has signed the study specific informed consent form. Exclusion Criteria: have already had a Patient Notifier™ alert since implant; had a prior device implant (PM or ICD); have not been discharged from the hospital since device implant; have evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records; cannot commit to the follow-up schedule; have a life expectancy of less than 1 year; are on a waiting list for a heart transplant; are less than 18 years old; are pregnant;

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Group<br>Patient Notifier turned OFF | Device: ICD implant + Patient Notifier turned OFF<br>* ICD implant, plus standard care, i.e. Patient Notifier turned off<br>|
| Experimental: Treatment group<br>Patient Notifier turned ON | Procedure: ICD Implant + Patient Notifier turned ON<br>* ICD implant. The Patient Notifier™ feature will be turned ON.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in device related anxiety, related to battery depletion, as assessed by the Duru Questionnaire (question 9) Reduction in device related anxiety, related to device malfunction, as assessed by the Duru Questionnaire (question 10) |  | 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in general anxiety Evolution over time in anxiety for the different personality types Cross-overs Sensitivity and Specificity of the Patient Notifier™ Number of appropriate/inappropriate ICD therapies Hospitalizations Mortality |  | 1year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary and secondary prevention for ventricular tachycardia