Actively Recruiting
Developing a Digital Aid to Improve ICD Decisions
Led by Stanford University · Updated on 2026-04-27
600
Participants Needed
2
Research Sites
130 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Developing a Digital Aid to Improve ICD Decisions
Who Can Participate
Eligibility Criteria
You may qualify if you...
Developmental Testing will attempt to abide by eligibility criteria identical to the planned criteria for the subsequent RCT, but may strategically deviate from these criteria to enhance the testing and development process.
- Meets or approximates minimal criteria for primary prevention ICD placement. ● Left Ventricular Ejection Fraction (LVEF) <35%.
- Clinical diagnosis of Heart Failure:
- Patients with severe ischemic dilated cardiomyopathy and underlying NYHA
- Class II or III Heart Failure, OR, Patients with severe nonischemic dilated cardiomyopathy and underlying NYHA Class II or III Heart Failure.
- Age ≥ 70 years old.
- Able to consent in English, Mandarin or Spanish and follow study instructions.
You will not qualify if you...
The exclusion criteria include any of the following:
- Past ICD implantation (not including pacemakers).
- Any indication for secondary prevention of SCD via ICD implantation.
- History of mechanical valve replacement.
- History of recent myocardial infarction within the last 40 days.
- History of recent revascularization within the past 90 days.
- History of familial or genetic disorders with a high-risk of ventricular arrhythmias, such as the long QT syndrome (LQTS) or hypertrophic cardiomyopathy (HCM).
- Any factors contraindicating ICD placement.
- Less than 6 months life expectancy and other clinical consideration,
- Unwilling or unable to consider ICD,
- Any contraindications to ambulati
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
Eastern Carolina University
Greenville, North Carolina, United States, 27858
Actively Recruiting
Research Team
R
Randall S Stafford, MD, PhD, MHS
CONTACT
D
Darlyne Esparza
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
3
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