PAtient NOtifier Feature for Reduction of Anxiety (Panoramic)

February 1, 2019 updated by: Abbott Medical Devices

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

362

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, CH-8091
        • Universitätsspital Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Group
Patient Notifier turned OFF
Device: ICD implant + Patient Notifier turned OFF
ICD implant, plus standard care, i.e. Patient Notifier turned off
Experimental: Treatment group
Patient Notifier turned ON
Procedure: ICD Implant + Patient Notifier turned ON
ICD implant. The Patient Notifier™ feature will be turned ON.

What is the study measuring?

Primary Outcome Measures

Outcome 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)
Time Frame: 12months
12months

Secondary Outcome Measures

Outcome 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
Time Frame: 1year
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Firat Duru, Prof., Universitätsspital Zürich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR06002HV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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