A Pilot Trial of Patient Decision Aids for Implantable Cardioverter-Defibrillators (ICDs)

Completed · Not applicable

Conditions studied: Systolic Heart Failure, Sudden Cardiac Death

In brief

The purpose of this study is to test the acceptability and feasibility of a "toolkit" of patient decision aids (PtDAs) for heart failure patients who are considering an ICD implant.

Key facts

Study ID

NCT02026102

Run by

University of Colorado, Denver

People needed

15

Starts

2014-09-01

Expected to finish

2016-11-01

Last updated by the study team

2019-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• systolic heart failure (defined as an ejection fraction less than 35%)
• have been referred for a primary prevention ICD
• Note: Patients referred for an ICD with cardiac resynchronization therapy are NOT excluded.

You may not qualify if…

• Already have an ICD
• Non-English speaking (as the tools we have developed are only available in English currently)
• Other ICD indications (e.g. secondary prevention, hypertrophic obstructive cardiomyopathy)
• Cognitive Impairment defined only as people with an inability to consent

Where it is running

• University of Colorado Hospital (UCH) — Aurora, Colorado, United States
• Kaiser Permanente of Colorado — Denver, Colorado, United States
• Denver VA Medical Center — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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