The Implantable Cardioverter-defibrillators (ICD)/Device Expectations, Adaptations, and Successes Study

Completed

Conditions studied: Depression, Anxiety, Post-traumatic Stress Disorder

In brief

The introduction of pacemakers and implantable cardioverter-defibrillators (ICDs) has substantially changed the medical and surgical management of patients with cardiac rhythm disease. In the case of patients with ICDs, these devices are programmed to deliver a strong electrical shocks. In adults, multiple studies have suggested that patients at risk of receiving shocks from their device have an increased prevalence of anxiety and depression. Very few studies have looked at this question in children. We propose to evaluate a cohort of patients age 6 to 20 with ICDs, compared to a cohort of patients with pacemakers, assessing each group for the presence of depressive and anxiety disorders, including post-traumatic stress disorder (PTSD).

Key facts

Study ID

NCT01040988

Run by

Boston Children's Hospital

People needed

166

Starts

2009-08-01

Expected to finish

2010-10-01

Last updated by the study team

2017-04-13

Who can join

Age: 6 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 6 through 20 at the time of enrollment for patients.
• Age ≥18 for caregiver
• Functioning pacemaker or ICD (explanted or inoperative devices do not qualify)
• Informed consent of parent or guardian as well as assent of study participant

You may not qualify if…

• Lack of English language fluency in patient and caregiver
• Hospitalization within 4 weeks of visit
• First implantation of ICD or pacemaker within 6 months of study enrollment

Where it is running

• Children's Hospital Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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