PAtient NOtifier Feature for Reduction of Anxiety

NCT00559559 | Completed

• 1 other identifier: CR06002HV
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

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

Conditions

Tachycardia, Ventricular

Keywords

Primary and secondary prevention for ventricular tachycardia

Outcome Measures

Primary Outcomes (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)

  12months

Secondary Outcomes (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

  1year

Study Arms (2)

Control Group

OTHER

Patient Notifier turned OFF

Device: ICD implant + Patient Notifier turned OFF

Treatment group

EXPERIMENTAL

Patient Notifier turned ON

Procedure: ICD Implant + Patient Notifier turned ON

Interventions

ICD implant + Patient Notifier turned OFF DEVICE

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

Control Group

ICD Implant + Patient Notifier turned ON PROCEDURE

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

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

UniversitätsSpital Zürich

Zurich, CH-8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 20207746 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Firat Duru, Prof.

  Universitätsspital Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

CH (1)