Actively Recruiting
A Non-interventional Observational Study Using Prolaio Digital Health Devices to Monitor Chronic Cardiovascular Conditions in Ambulatory Patients
Led by Prolaio · Updated on 2026-02-19
5000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing patients with various chronic cardiovascular conditions such as aortic stenosis, heart failure, hypertension, and cardiomyopathies to study the natural progression of these diseases. The study aims to collect physiological data over time to better understand these conditions without introducing new treatments or interventions. Participants include ambulatory adults with diagnosed cardiovascular disease who live in the United States. The study involves the ongoing use of Prolaio Digital Health Devices to monitor participants' health status. These non-invasive devices collect data continuously while participants go about their daily lives, allowing researchers to track disease progression longitudinally. The study does not involve any treatment assignment or drug administration, focusing solely on observation and data collection. Participants will be assessed regularly, with clinical status evaluations occurring every 90 days to monitor changes over time. Data collected include physiological measurements from the digital devices, along with participant responses to study assessments. The study emphasizes compliance with data collection protocols and understanding instructions provided in English. Participation duration extends through multiple 90-day cycles, enabling researchers to observe sustained health trends and outcomes.
CONDITIONS
Brief Title
Study of the Progression of Chronic Cardiovascular Conditions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age and older
- Ability to understand study assessments and give informed consent to data collection
- Ability to comply with the study protocol
- Ability to understand and respond to instructions in English
- Has diagnosis of qualifying Cardiovascular Disease(s) including but not limited to heart failure, aortic stenosis, hypertrophic cardiomyopathy, hypertension, dilated cardiomyopathy
- Resides in the United States
You will not qualify if you...
- Allergy to adhesive used in biosensor patch
- Life threatening disease outside cardiovascular area under study, such as active cancer or liver failure; end-stage kidney disease
- Severe cardiovascular disease defined by hospital admission for cardiac diagnosis within 30 days of enrollment or New York Heart Association functional class IV
- Self-reported weight of 400 pounds or greater
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Ongoing with assessments every 90 days
Participants are observed using digital health devices to monitor their chronic cardiovascular conditions over time.
Assessments every 90 days
Trial Site Locations
Total: 1 location
1
Prolaio
Chicago, Illinois, United States, 60606
Actively Recruiting
Research Team
S
Study Team OCORO Study
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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