RecruitingNCT07420907

Study of the Progression of Chronic Cardiovascular Conditions

A Non-interventional Observational Study of the Sustained Use of Prolaio Digital Health Devices to Monitor the Natural History of Chronic Cardiovascular Conditions in Ambulatory Patients

Sponsor

Prolaio

Enrollment

5,000 participants

Start Date

Oct 30, 2025

Study Type

OBSERVATIONAL

Conditions

Heart Failure Hypertension Dilated Cardiomyopathy Hypertension (HTN)Aortic Stenosis Cardiovascular Disease (CVD)Aortic Stenosis Disease Hypertrophic Cardiomyopathy Patients Hypertrophic Cardiomyopathy Without Obstruction Hypertrophic Cardiomyopathy, Obstructive Dilated Cardiomyopathy (DCM)Dilated Cardiomyopathy, Familial

Summary

This study will collect physiologic data in patients with cardiovascular conditions and observe the natural history of those conditions for research purposes.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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) (CVD) including but not limited to: HF, AS, HCM, HTN, DCM, etc.
Resides in the United States

Exclusion Criteria4

Allergy to adhesive used in biosensor patch
Life threatening disease process outside of area under study, such as actively treated cancer or pre/post-transplant such as hepatic failure; end-stage renal disease.
Severe CVD defined by hospital admission for cardiac diagnosis within 30 days of enrollment or documentation of NYHA functional class IV
Self-reported weight of 400 pounds or greater