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Recruiting

NCT Number: NCT07420907

Study of the Progression of Chronic Cardiovascular Conditions

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

Recruiting

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Key information

Conditions

Cardiovascular Disease (CVD) Aortic Stenosis Aortic Stenosis Disease Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiomyopathy, Hypertrophic Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dilated Cardiomyopathy Dilated Cardiomyopathy (DCM) Dilated Cardiomyopathy, Familial Genetic Diseases, Inborn Heart Diseases Heart Failure Heart Valve Diseases Hypertension Hypertension (HTN) Hypertrophic Cardiomyopathy Patients Hypertrophic Cardiomyopathy Without Obstruction Hypertrophic Cardiomyopathy, Obstructive Laminopathies Vascular Diseases Ventricular Outflow Obstruction familial dilated cardiomyopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prolaio

Chicago, Illinois, 60606, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Longitudinal Assessment of Clinical Status

    Time frame: Baseline through each 90-day cycle

    Measured by Heart Rate (beats per minute)

  2. Longitudinal Assessment of Clinical Status

    Time frame: Baseline through each 90-day cycle

    Heart Rate Variability (per millisecond)

  3. 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)

  4. Longitudinal Assessment of Clinical Status

    Time frame: Baseline through each 90-day cycle

    Breaths per minute

Study contacts

Contact information is provided by the study sponsor or research team.

Study Team OCORO Study

CONTACT

[email protected]

1-855-869-9054

Sponsors and collaborators

Lead sponsor

Prolaio

Industry

Registry information

Official study title

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

Acronym: OCORO

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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