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โ† Trials
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Developing a Digital Aid to Improve ICD Decisions

RecruitingNAAges 60 Years - anyAllStanford University
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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. โ— 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 โ‰ฅ 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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What it tests

  • Online, patient-facing decision-making aid (app) with personalized risk information.
  • Implantable Cardioverter Defibrillator (ICD)
  • Online, patient-facing decision-making app without personalized risk information.
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Where

2 sites
University of California, San Francisco
San Francisco, United States
Eastern Carolina University
Greenville, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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