Tachycardia, Ventricular
Conditions
Keywords
Primary and secondary prevention for ventricular tachycardia
Brief summary
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
Interventions
DEVICEICD implant + Patient Notifier turned OFF
ICD implant, plus standard care, i.e. Patient Notifier turned off
PROCEDUREICD Implant + Patient Notifier turned ON
ICD implant. The Patient Notifier™ feature will be turned ON.
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Switzerland
Outcome results
None listed