Developing a Digital Aid to Improve ICD Decisions

Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death. A major problem is sudden cardiac death, when the damaged heart develops an abnormal pattern of electrical conduction that can result in cessation of heart activity. While placement of an Implantable Cardioverter-Defibrillator (ICD) in a patient's chest can help prevent sudden cardiac death, these devices have several important downsides. This protocol focuses on development of a digital decision aid that helps heart failure patients make informed decisions that balance the benefits and downsides of ICD placement. This protocol covers the use of participant surveys, focus groups, and interviews to obtain the needed background information to guide the development of this digital tool, which will be subsequently tested against usual care in a randomized clinical trial. The study design is best described as a mixed methods evaluation and refinement of a digital app to improve ICD decision-making. In the future, the present protocol will be modified to create a new protocol that covers the needed human subjects requirements for performance of this clinical trial.

NCT Number	NCT07084142
Lead Sponsor	Stanford University Collaborators: National Heart, Lung, and Blood Institute (NHLBI), University of California, San Francisco, East Carolina University
Conditions	Heart Failure and Reduced Ejection Fraction
Enrollment	600 participants
Start Date	2025-08-01
Primary Completion	2026-08 (estimated)
Study Completion	2028-02 (estimated)
Updated on ClinicalTrials.gov	2026-04-27