Remote Monitoring and Optimization of Heart Failure Therapy

Sponsor
Zoll Medical Corporation
Study ID
NCT07622472
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Wearable Monitoring Device for Heart Failure — DEVICE
    Participants assigned to the intervention group will use a noninvasive wearable physiological monitoring device (Heart Failure Management System, HFMS) designed to continuously collect data related to cardiopulmonary status, including heart rate, respiratory parameters, activity levels, and indicators of fluid status (Thoraic Fluid Index = TFI). Clinical care teams perform regular reviews of device-derived data and may respond to alerts or trends suggestive of worsening heart failure. Based on these data, the care team may adjust patient management, including modification of guideline-directed medical therapy or scheduling of follow-up assessments. The device does not deliver therapy and is used to support clinical decision-making in the outpatient management of heart failure.

Study Details

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.

Key Dates

First listed
Jun 3, 2026
Start date
Oct 1, 2026
Status verified
Jun 2026
Primary completion
Aug 1, 2028
Completion
Aug 1, 2029

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control Group
    Participants receive standard medical care for heart failure according to local clinical practice without use of the HFMS device.
  • Active Comparator: Intervention Group
    Participants receive standard medical care in addition to remote monitoring using the Heart Failure Management System (HFMS). Clinical teams review device data and may adjust treatment based on observed trends and alerts.

Primary Outcome Measure

Hierarchical Composite Outcome (Win Ratio) [ Time Frame: 90 days ]

Central Contacts

Find similar trials

Nationwide
Heart failure trialsCardiology trialsHeart disease trials

Related Studies