PAtient NOtifier Feature for Reduction of Anxiety

NCT ID: NCT00559559

Last Updated: 2019-02-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Tachycardia, Ventricular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Group

Patient Notifier turned OFF

Group Type OTHER

ICD implant + Patient Notifier turned OFF

Intervention Type DEVICE

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

Treatment group

Patient Notifier turned ON

Group Type EXPERIMENTAL

ICD Implant + Patient Notifier turned ON

Intervention Type PROCEDURE

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

Intervention Type DEVICE

ICD Implant + Patient Notifier turned ON

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

Intervention Type PROCEDURE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Firat Duru, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universitätsspital Zürich

Locations

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UniversitätsSpital Zürich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

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.

Reference Type DERIVED
PMID: 20207746 (View on PubMed)

Other Identifiers

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CR06002HV

Identifier Type: -

Identifier Source: org_study_id

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