NCT07084142 · Stanford University
Developing a Digital Aid to Improve ICD Decisions
What this study 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.
View original scientific description
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.
Interventions
OTHER
Online, patient-facing decision-making aid (app) with personalized risk information.
The online, patient-facing decision-making aid will have the following features: 1. Clinical Data Input, 2. Introduction via Animated Video, 3. Common Questions, 4. Check-In Quiz, 5. Risk and Values Exploration based on patient specific information, 6. Wrap-Up, 7. Patient-Physician Worksheet, These steps will be completed by the patient in advance of a provider visit where a shared-decision making process will decide whether an ICD is an appropriate sudden cardiac death-prevention strategy to pursue.
DEVICE
Implantable Cardioverter Defibrillator (ICD)
Some participants, in their course of medical care unrelated to the study intervention, will undergo implantation of an ICD.
OTHER
Online, patient-facing decision-making app without personalized risk information.
The online, patient-facing decision-making aid will have the following features: 1) Clinical Data Input, 2) Introduction via Animated Video, 3) Common Questions, 4) Check-In Quiz, 5) Generic Risk and Values Exploration without patient specific information, 6) Wrap-Up, 7) Patient-Physician Worksheet, These steps will be completed by the patient in advance of a provider visit where a shared-decision making process will decide whether an ICD is an appropriate sudden cardiac death-prevention strategy to pursue.
Primary outcome measures
Decisional Conflict Scale (DCS)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- San Francisco, California
- Greenville, North Carolina
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of California, San Francisco, East Carolina University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2026 · Source of record for eligibility and locations