A digital tool to help decide about an ICD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project develops a digital decision aid for heart failure patients considering an ICD. It uses surveys, focus groups, and interviews to gather background information and refine the tool. The digital aid will be tested in a randomized trial against usual care to see if it helps patients make more informed choices about ICD placement.

Why it matters

Who can join: the full rules

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:

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 it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Eastern Carolina University
  Greenville, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Randall S Stafford, MD, PhD — Stanford University
• Study coordinator: Randall S Stafford, MD, PhD, MHS
• Email: rstafford@stanford.edu
• Phone: 650-724-2400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.