PAtient NOtifier Feature for Reduction of Anxiety

Not Applicable

Completed

• Conditions: Tachycardia, Ventricular
• Interventions: Device: ICD implant + Patient Notifier turned OFF; Procedure: ICD Implant + Patient Notifier turned ON

• Registration Number: NCT00559559
• Lead Sponsor: Abbott Medical Devices

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Study Start: 2007-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	ICD implant + Patient Notifier turned OFF	Patient Notifier turned OFF
Treatment group	ICD Implant + Patient Notifier turned ON	Patient Notifier turned ON

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

UniversitätsSpital Zürich; 🇨🇭 Zürich, Switzerland