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Digital Aid for ICD Decisions in Heart Failure

This study is developing a digital tool to help people with heart failure and reduced ejection fraction (a measure of how well your heart pumps blood) make informed decisions about getting an Implantable Cardioverter-Defibrillator (ICD). An ICD is a device placed in your chest that can prevent sudden cardiac death, but it also has downsides. The study will test two versions of an online app: one with personalized risk information and one with general risk information. The main goal is to see if these apps reduce "decisional conflict" (how unsure or conflicted you feel about a medical decision). You might be able to join if you are 60 years or older, have advanced heart failure, and meet criteria for a primary prevention ICD.

Study design
This interventional study plans to enroll 600 participants. It is developing a digital decision aid for heart failure patients.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your decisional conflict will be measured immediately after your decision-making visit and again at 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07084142

Developing a Digital Aid to Improve ICD Decisions

Recruiting
NAAges 60+InterventionalHealth services
Stanford University
~600 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:Online, patient-facing decision-making aid (app) with personalized risk information.Implantable Cardioverter Defibrillator (ICD)Online, patient-facing decision-making app without personalized risk information.

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Decisional Conflict Scale (DCS)
Measured over Immediately after decision-making visit as well as at 3 months.

Conditions

Heart Failure and Reduced Ejection Fraction

Explore related trials

Heart Failure

NCT07084142

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Eastern Carolina University

    Greenville, North Carolinastudy coordinator listed

    Recruiting

  • University of California, San Francisco

    San Francisco, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Randall S Stafford, MD, PhD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Randall S Stafford, MD, PhD, MHS
[email protected]
650-724-2400
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Decisional Conflict Scale (DCS)Immediately after decision-making visit as well as at 3 months.

    The Decisional Conflict Scale is a validated, 16-item questionnaire scale assessing whether a participant feels conflicted regarding a past medical decision. The range is 0 to 100 with higher scores indicating more conflict, a negative outcome.