Study of the Progression of Chronic Cardiovascular Conditions (OCORO)

February 16, 2026 updated by: Prolaio

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

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60606
        • Recruiting
        • Prolaio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants who have been diagnosed including but not limited to the following Cardiovascular Disease types: Aortic Stenosis, Heart Failure, Hypertension Obstructive Cardiomyopathy, Dilated Cardiomyopathy

Description

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) (CVD) including but not limited to: HF, AS, HCM, HTN, DCM, etc.
  • 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cardiovascular Disease (CVD)
Participants who have been diagnosed including but not limited to the following Cardiovascular Disease types: Aortic Stenosis, Heart Failure, Hypertension Obstructive Cardiomyopathy, Dilated Cardiomyopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Longitudinal Assessment of Clinical Status
Time Frame: Baseline through each 90-day cycle
Measured by Heart Rate (beats per minute)
Baseline through each 90-day cycle
Longitudinal Assessment of Clinical Status
Time Frame: Baseline through each 90-day cycle
Heart Rate Variability (per millisecond)
Baseline through each 90-day cycle
Longitudinal Assessment of Clinical Status
Time Frame: Baseline through each 90-day cycle
percentage of Atrial Fibrillation Burden (duration of time per day of demonstrated AF)
Baseline through each 90-day cycle
Longitudinal Assessment of Clinical Status
Time Frame: Baseline through each 90-day cycle
Breaths per minute
Baseline through each 90-day cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prolaio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2025

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-030

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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