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Surface ECG and Sensor Data Acquisition of HF Recovery

Study Type/Phase: Feasibility
Status: Not Recruiting

Heart Failure (HF) affects 5.8 million patients in the United States and 23 million globally. There is a clinical need for cost-effective, less burdensome, and more effective treatment options. The goal is to enable healthcare providers to manage and treat heart failure in a way that ultimately reduces or prevents hospital readmissions.

To gather the data towards this goal, this study uses a lightweight, noninvasive device to collect cardiac data. The device uses custom-made, patch sensors that temporarily adhere to the torso of the patient and connect to a recording unit. The sensors, which are like patch electrodes used to collect electrocardiograms, collect physiological data that may correlate with changing heart failure status. The data collected will be used to investigate whether heart failure episodes can be predicted before the onset of symptoms so that patients and providers can take action to prevent hospital readmission. The intent of this study is for data collection and research purposes only.

Up to 50 patients will be enrolled at El Camino Hospital Mountain View location.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • Male and female subjects at least 18 years of age.
  • Subjects who are admitted for a heart failure episode requiring therapeutic intervention.
  • Subjects who are allergic to or have had known adverse reaction to medical adhesives.
  • Subjects who have active skin breakdown, erythema, or other signs of infection in the torso region where the study device is applied.
  • Subjects with any other condition that as judged by the investigator may make data collection under an observational study inappropriate.
  • Subjects who cannot provide or have diminished capacity to provide informed consent.
  • Patients with a life expectancy shorter than the protocol duration shall not be included in the study.

Principal Investigator

Geoffrey Yoon, MD

Sponsor

Element Science Inc.

Contact

Kara Turner, Clinical Research Coordinator
650-962-4562
Kara_Turner@elcaminohealth.org

 

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