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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07420907

Acronym

OCORO

Enrollment

5000

Registered

2026-02-19

Start date

2025-10-30

Completion date

2030-10-01

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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: HF, AS, HCM, HTN, DCM, etc. Additional CVD may be included at discretion of the investigators. * Resides in the United States

Exclusion criteria

* Allergy to adhesive used in biosensor patch * Life-threatening disease process outside of area under study, such as actively treated cancer or being actively considered for organ pre-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 * \-- For participants who do not qualify due to this exclusion, and have not been hospitalized within 30 days of enrollment, they may reapply to enroll in the study * Self-reported weight of 400 pounds or greater

Design outcomes

Primary

Measure	Time frame	Description
Longitudinal Assessment of Clinical Status	Baseline through each 90-day cycle	Measured by Heart Rate (beats per minute)

Countries

United States

Contacts

CONTACTStudy Team OCORO Study

OCOROstudy@prolaio.com1-855-869-9054

Outcome results