NCT07084142Recruiting
Developing a Digital Aid to Improve ICD Decisions
Developing "A Digital Shared Decision-Making Aid to Improve Patient-Centered Outcomes in Implantable Cardioverter-Defibrillator (ICD) Decisions Among Older Patients"
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 16 Jul 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Stanford University
- Diseases
- Heart failure
- NCT number
- NCT07084142
What you commit to
- Study type: Interventional
- Planned participants: 600
- From 1 Aug 2025 to the primary completion date, 31 Aug 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of mechanical valve replacement.
- History of recent myocardial infarction within the last 40 days.
- History of recent revascularization within the past 90 days.
Lab values
- History of familial or genetic disorders with a high-risk of ventricular arrhythmias, such as the long QT syndrome (LQTS) or hypertrophic cardiomyopathy (HCM).
Other
- The exclusion criteria include any of the following:
- Past ICD implantation (not including pacemakers).
- Any indication for secondary prevention of SCD via ICD implantation.
- 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
Who the study is looking for
- 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.
Criteria the registry did not label
- 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.
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eastern Carolina University Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.