Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
362 participants
INTERVENTIONAL
2007-12-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control Group
Patient Notifier turned OFF
ICD implant + Patient Notifier turned OFF
ICD implant, plus standard care, i.e. Patient Notifier turned off
Treatment group
Patient Notifier turned ON
ICD Implant + Patient Notifier turned ON
ICD implant. The Patient Notifier™ feature will be turned ON.
Interventions
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ICD implant + Patient Notifier turned OFF
ICD implant, plus standard care, i.e. Patient Notifier turned off
ICD Implant + Patient Notifier turned ON
ICD implant. The Patient Notifier™ feature will be turned ON.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Firat Duru, Prof.
Role: PRINCIPAL_INVESTIGATOR
Universitätsspital Zürich
Locations
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UniversitätsSpital Zürich
Zurich, , Switzerland
Countries
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References
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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.
Other Identifiers
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CR06002HV
Identifier Type: -
Identifier Source: org_study_id
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