PAtient NOtifier Feature for Reduction of Anxiety (Panoramic)

Abbott

Status

Completed

Conditions

Tachycardia, Ventricular

Treatments

Device: ICD implant + Patient Notifier turned OFF

Procedure: ICD Implant + Patient Notifier turned ON

Study type

Interventional

Funder types

Industry

Identifiers

NCT00559559

CR06002HV

Details and patient eligibility

About

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

Enrollment

362 patients

Sex

All

Ages

18+ years old

Volunteers

No 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;