Panoramic: PAtient NOtifier Feature for Reduction of Anxiety

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00559559
• Collaborator: (none)
• Enrollment: 362
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 10.1

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Tachycardia, Ventricular	Device: ICD implant + Patient Notifier turned OFF; Procedure: ICD Implant + Patient Notifier turned ON	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 362 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: PAtient NOtifier Feature for Reduction of Anxiety: A Multicenter ICD Study
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Control Group Patient Notifier turned OFF	Device: ICD implant + Patient Notifier turned OFF; ICD implant, plus standard care, i.e. Patient Notifier turned off
Experimental: Treatment group Patient Notifier turned ON	Procedure: ICD Implant + Patient Notifier turned ON; ICD implant. The Patient Notifier™ feature will be turned ON.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UniversitätsSpital Zürich	Zürich		Switzerland	CH-8091

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Firat Duru, Prof., Universitätsspital Zürich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00559559
• Other Study ID Numbers: CR06002HV
• First Posted: Nov 16, 2007
• Last Update Posted: Feb 4, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Abbott Medical Devices: Primary and secondary prevention for ventricular tachycardia
• Additional relevant MeSH terms: Tachycardia; Tachycardia, Ventricular

Study Results

No Results Posted as of Feb 4, 2019