Observational Study Using Prolaio Digital Health Devices to Monitor Chronic Cardiovascular Conditions in Adults

What this Trial Is About

Researchers are observing the natural progression of various chronic cardiovascular diseases in ambulatory patients using digital health devices. The study aims to collect physiological data from patients diagnosed with conditions such as aortic stenosis, heart failure, hypertension, hypertrophic and dilated cardiomyopathies, among others, to better understand these diseases over time. Participants will use Prolaio digital health devices to monitor their cardiovascular status while living in the community. The study is non-interventional and observational, focusing on sustained data collection rather than treatment. Patients diagnosed with qualifying cardiovascular diseases will be included, and the study will observe their clinical status during repeated 90-day cycles. During participation, patients will undergo regular assessments of their clinical condition through data collected by the devices. Researchers will monitor the longitudinal clinical status from baseline and throughout each 90-day cycle to assess disease progression. The study is planned to run from October 2025 through October 2030, allowing for extended observation of participants in the United States.

Study of the Progression of Chronic Cardiovascular Conditions