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PAtient NOtifier Feature for Reduction of Anxiety (Panoramic)

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ClinicalTrials.gov Identifier: NCT00559559
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Tachycardia, Ventricular Device: ICD implant + Patient Notifier turned OFF Procedure: ICD Implant + Patient Notifier turned ON Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 362 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PAtient NOtifier Feature for Reduction of Anxiety: A Multicenter ICD Study
Study Start Date : December 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559559


Locations
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Switzerland
UniversitätsSpital Zürich
Zürich, Switzerland, CH-8091
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Firat Duru, Prof. Universitätsspital Zürich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00559559     History of Changes
Other Study ID Numbers: CR06002HV
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

Keywords provided by Abbott Medical Devices:
Primary and secondary prevention for ventricular tachycardia

Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes