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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

About this trial

This is an interventional prevention trial for Tachycardia, Ventricular focused on measuring Primary and secondary prevention for ventricular tachycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Time Frame

12months

Secondary Outcome Measure Information:

Title

Time Frame

1year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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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