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New digital aid helps heart patients make tough ICD choices

NCT ID NCT07084142

Knowledge-focused Sponsor: Stanford University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to create a digital decision-making aid for older adults with heart failure who are considering getting an implantable cardioverter-defibrillator (ICD). The tool will help patients weigh the benefits of preventing sudden cardiac death against the downsides of the device. Researchers will gather input from 600 participants through surveys and interviews to refine the tool, which will later be tested in a clinical trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac Death, Sudden, Cardiac heart failure systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure and reduced ejection fraction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Eastern Carolina University

    RECRUITING

    Greenville, North Carolina, 27858, United States

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

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