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Life sciences · Interventional Study
ClinicalTrials.gov · October 5, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07622472). This is a study registration, not published results. Lead sponsor: Zoll Medical Corporation. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 800 participants (ESTIMATED). Conditions: Heart Failure. Interventions: DEVICE: Wearable Monitoring Device for Heart Failure. Primary outcome measures: Hierarchical Composite Outcome (Win Ratio) , 90 days. Brief summary: Heart failure is a condition in which the heart cannot pump blood effectively, often leading to symptoms such as shortness of breath and fluid retention. After hospitalization for heart failure, patients remain at high risk of worsening symptoms, emergency visits, and hospital readmission. This study is designed to evaluate whether using a wearable monitoring device, called the Heart Failure Management System (HFMS), can help improve the management of patients after a recent hospitalization for heart failure. Participants in this study will be randomly assigned to one of two groups. One group will receive standard medical care alone. The other group will receive standard medical care in combination with the HFMS device. The HFMS device is worn on the body and continuously collects information such as heart rate, breathing, activity level, and signs of fluid accumulation. These data are reviewed by the clinical care team and may help detect early worsening of heart failure. Participants will wear the device for 90 days (if assigned to the device group) and will be followed for up to one year. During the study, information will be collected on serious health events such as death, hospitalizations, emergency visits, and changes in heart failure status, as well as quality of life. The goal of this study is to determine whether this monitoring approach can improve outcomes for patients with heart failure by enabling earlier and more effective clinical management.