Digital aid to help older adults with HFrEF decide about ICD placement.

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 mixed-methods project will develop and refine a patient-facing digital decision aid using surveys, focus groups, and interviews among patients with heart failure and reduced ejection fraction. The development phase will capture participant feedback and demographic data in a REDCap database and iterate on prototypes, including versions with and without personalized risk estimates. The finalized tool will then be tested against usual care in a planned randomized trial to see if it improves decision quality. Recruitment focuses on patients aged 70 or older who approximate criteria for primary-prevention ICD placement and who can consent in English, Mandarin, or Spanish.

Why it matters

Who can join: the full rules

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

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Biomarkers linked to reverse heart healing in people with heart failure and reduced ejection fraction

  This study tests blood biomarkers and imaging data to see why some people with HFrEF improve their heart function after standard treatment.

  Recruiting Ruijin Hospital Luwan Branch · Shanghai, Shanghai Municipality · NCT07701876

• Selenium supplementation for people with heart failure

  This trial will test whether taking a daily selenium supplement helps people with heart failure avoid hospitalization and reduce the risk of death.

  Recruiting at 11 sites Phase 3 Skane University Hospital · Oslo and 10 other locations · NCT07543562

• How doctors’ reminders about iron treatment may change IV iron use in adults with heart failure

  This trial tests whether sending doctors reminders about iron deficiency guidelines helps them use IV iron more often in hospitalized adults with heart failure who are iron deficient.

  Recruiting Kaiser Permanente · Pleasanton, California · NCT07467668

• Comparing three specialist pacemakers to improve heart pumping and reduce rhythm problems

  This study will test three types of specialist pacemakers in people with heart failure and reduced ejection fraction to see which best improves symptoms and heart rhythms over six months.

  Recruiting Imperial College London · London, Greater London · NCT07430553

• Comparing cardiac contractility modulation (CCM) to usual care for people with reduced ejection fraction and NYHA class III heart failure

  This study tests whether cardiac contractility modulation (CCM) reduces deaths and heart failure hospital stays in Medicare‑eligible adults with NYHA class III heart failure and an ejection fraction of 25–45%.

  Recruiting Impulse Dynamics · Marlton, New Jersey · NCT07209098

• MitraClip for secondary (functional) mitral regurgitation with cardiac MRI scar measurement

  The study will try to see if the amount of scar (fibrosis) seen on cardiac MRI predicts left‑ventricular recovery and clinical outcomes after MitraClip in people with heart failure and reduced ejection fraction.

  Recruiting Minneapolis Heart Institute Foundation · Minneapolis, Minnesota and 5 other locations · NCT07131631

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.