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PAtient NOtifier Feature for Reduction of Anxiety (Panoramic)

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00559559
First received: November 15, 2007
Last updated: July 12, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention
Tachycardia, Ventricular
 Device: ICD implant + Patient Notifier turned OFF
Procedure: ICD Implant + Patient Notifier turned ON

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: PAtient NOtifier Feature for Reduction of Anxiety: A Multicenter ICD Study

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by St. Jude Medical:

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) [ Time Frame: 12months ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 1year ] [ Designated as safety issue: Yes ]

Enrollment: 362
Study Start Date: December 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559559

Locations
Switzerland
UniversitätsSpital Zürich
Zürich, Switzerland, CH-8091
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Firat Duru, Prof. UniversitätsSpital Zürich
  More Information

No publications provided by St. Jude Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christophe Bailleul, St. Jude Medical
ClinicalTrials.gov Identifier: NCT00559559     History of Changes
Other Study ID Numbers: CR06002HV
Study First Received: November 15, 2007
Last Updated: July 12, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by St. Jude Medical:
Primary and secondary prevention for ventricular tachycardia

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013