Skip to main content
OpenTrials
Completed

NCT Number: NCT00559559

PAtient NOtifier Feature for Reduction of Anxiety

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UniversitätsSpital Zürich

Zurich, CH-8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

ICD implant + Patient Notifier turned OFF

Device

ICD implant, plus standard care, i.e. Patient Notifier turned off

ICD Implant + Patient Notifier turned ON

Procedure

ICD implant. The Patient Notifier™ feature will be turned ON.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: Panoramic

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Nov 16, 2007
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.