NCT07084142 Developing a Digital Aid to Improve ICD Decisions
| NCT ID | NCT07084142 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Heart Failure and Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2025-08-01 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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. Inclusion Criteria: * 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. Exclusion Criteria: 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
Contact & Investigator
Randall S Stafford, MD, PhD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT07084142 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Heart Failure and Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07084142 currently recruiting?
Yes, NCT07084142 is actively recruiting participants. Contact the research team at rstafford@stanford.edu for enrollment information.
Where is the NCT07084142 trial being conducted?
This trial is being conducted at San Francisco, United States, Greenville, United States.
Who is sponsoring the NCT07084142 clinical trial?
NCT07084142 is sponsored by Stanford University. The principal investigator is Randall S Stafford, MD, PhD at Stanford University. The trial plans to enroll 600 participants.
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