Developing a Digital Aid to Improve ICD Decisions

NCT07084142 | Recruiting FDA Device

• 2 other identifiers: IRB-79108R01HL173578
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure and Reduced Ejection Fraction

Keywords

heart failure; HFrEF; sudden cardiac death; patient education; shared decision-making; arrhythmia; implantable cardioverter-defibrillator

Outcome Measures

Primary Outcomes (1)

• Decisional Conflict Scale (DCS)

  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.

  Immediately after decision-making visit as well as at 3 months.

Other Outcomes (1)

• System Usability Scale (SUS)

  Day 1 (SUS will be assessed immediately following testing of the app, or a specific module of the app)

Study Arms (3)

Exposure to digital decision-making app with personal risk information

EXPERIMENTAL

The participant will use the pre-visit, participant-facing app with personal risk information derived from participant characteristics. During a clinical encounter, the clinician will have access to an abbreviated clinician-facing digital tool that displays the same personalized information.

Other: Online, patient-facing decision-making aid (app) with personalized risk information.; Device: Implantable Cardioverter Defibrillator (ICD)

Use of a digital decision-making app without personalized risk information.

EXPERIMENTAL

The participant will use the pre-visit, participant-facing app without personal risk information. During a clinical encounter, the clinician will have access to an abbreviated clinician-facing digital tool.

Device: Implantable Cardioverter Defibrillator (ICD); Other: Online, patient-facing decision-making app without personalized risk information.

Usual clinical care

PLACEBO COMPARATOR

Participant will receive usual clinical care without use of the digital decision-making app.

Device: Implantable Cardioverter Defibrillator (ICD)

Interventions

Implantable Cardioverter Defibrillator (ICD) DEVICE

Some participants, in their course of medical care unrelated to the study intervention, will undergo implantation of an ICD.

Exposure to digital decision-making app with personal risk information; Use of a digital decision-making app without personalized risk information.; Usual clinical care

Online, patient-facing decision-making app without personalized risk information. OTHER

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.

Use of a digital decision-making app without personalized risk information.

Online, patient-facing decision-making aid (app) with personalized risk information. OTHER

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.

Exposure to digital decision-making app with personal risk information

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of California, San Francisco: collaborator
• East Carolina University: collaborator

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Eastern Carolina University

Greenville, North Carolina, 27858, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure; Death, Sudden, Cardiac; Arrhythmias, Cardiac

Interventions

Amyloid; Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins; Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Randall S Stafford, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Randall S Stafford, MD, PhD, MHS

CONTACT

650-724-2400; rstafford@stanford.edu

Darlyne Esparza

CONTACT

desparza@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Three-arm randomized, parallel clinical trial. Arm A: digital decision-making tool with personalized risk information, Arm B: digital decision-making tool without personalized risk information, and Arm C: usual clinical care without digital tool use.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD from this developmental stage will be available after January 1, 2027 for a period of at least 5 years.
• Access Criteria: Electronic access will be provided to IPD upon approval of reasonable requests.

Locations

US (2)