PAtient NOtifier Feature for Reduction of Anxiety

Tachycardia, Ventricular Clinical Trial

— Panoramic  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559559
• Other study ID #: CR06002HV
• Status: Completed
• Phase: N/A
• Start date: December 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular

Intervention

Device:
• ICD implant + Patient Notifier turned OFF
ICD implant, plus standard care, i.e. Patient Notifier turned off

Procedure:
• ICD Implant + Patient Notifier turned ON
ICD implant. The Patient Notifier™ feature will be turned ON.

Locations

Country	Name	City	State
Switzerland	UniversitätsSpital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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