PAtient NOtifier Feature for Reduction of Anxiety (Panoramic)
Primary Purpose
Tachycardia, Ventricular
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
ICD implant + Patient Notifier turned OFF
ICD Implant + Patient Notifier turned ON
Sponsored by
About this trial
This is an interventional prevention trial for Tachycardia, Ventricular focused on measuring Primary and secondary prevention for ventricular tachycardia
Eligibility 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;
Sites / Locations
- UniversitätsSpital Zürich
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control Group
Treatment group
Arm Description
Patient Notifier turned OFF
Patient Notifier turned ON
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00559559
First Posted
November 15, 2007
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT00559559
Brief Title
PAtient NOtifier Feature for Reduction of Anxiety
Acronym
Panoramic
Official Title
PAtient NOtifier Feature for Reduction of Anxiety: A Multicenter ICD Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia, Ventricular
Keywords
Primary and secondary prevention for ventricular tachycardia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
362 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Other
Arm Description
Patient Notifier turned OFF
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Patient Notifier turned ON
Intervention Type
Device
Intervention Name(s)
ICD implant + Patient Notifier turned OFF
Intervention Description
ICD implant, plus standard care, i.e. Patient Notifier turned off
Intervention Type
Procedure
Intervention Name(s)
ICD Implant + Patient Notifier turned ON
Intervention Description
ICD implant. The Patient Notifier™ feature will be turned ON.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Firat Duru, Prof.
Organizational Affiliation
Universitätsspital Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
UniversitätsSpital Zürich
City
Zürich
ZIP/Postal Code
CH-8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
20207746
Citation
Duru F, Dorian P, Favale S, Perings C, Pedersen SS, Willems V; PAtient NOtifier Feature for Reduction of Anxiety: A Multicenter ICD Study investigators. Effects of an alert system on implantable cardioverter defibrillator-related anxiety: rationale, design, and endpoints of the PANORAMIC multicentre trial. Europace. 2010 May;12(5):726-30. doi: 10.1093/europace/euq026. Epub 2010 Mar 5.
Results Reference
derived
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PAtient NOtifier Feature for Reduction of Anxiety
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