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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
362
ICD implant, plus standard care, i.e. Patient Notifier turned off
ICD implant. The Patient Notifier™ feature will be turned ON.
UniversitätsSpital Zürich
Zurich, Switzerland
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)
Time frame: 12months
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
Time frame: 1year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.