Recruiting

Observational Study

Sponsor:

Prolaio

Code:

NCT07420907

Conditions

Cardiovascular Disease (CVD)

Heart Failure

Aortic Stenosis

Aortic Stenosis Disease

Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Cardiovascular Disease (CVD)

Heart Failure

Aortic Stenosis

Aortic Stenosis Disease

Hypertension

Study ID

NCT07420907

Start date

Oct 30, 2025

Status verified date

Aug, 2026

Completion date

Oct, 2030

Anticipated

Primary completion date

Oct, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Longitudinal Assessment of Clinical Status [ Time Frame: Baseline through each 90-day cycle ]
  • Longitudinal Assessment of Clinical Status [ Time Frame: Baseline through each 90-day cycle ]
  • Longitudinal Assessment of Clinical Status [ Time Frame: Baseline through each 90-day cycle ]
  • Longitudinal Assessment of Clinical Status [ Time Frame: Baseline through each 90-day cycle ]

Central Contacts and Locations

Central contacts

Study Team OCORO Study

1-855-869-9054OCOROstudy@prolaio.com

Locations

Prolaio

Recruiting

Chicago, Illinois, United States, 60606

More Information

Sponsor

Prolaio

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Prolaio on 2026-08-12.