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Recruiting NCT07420907

Study of the Progression of Chronic Cardiovascular Conditions

— Observational Cardiovascular Disease (CVD) Heart Failure Aortic Stenosis Aortic Stenosis Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiovascular Disease (CVD), Heart Failure, Aortic Stenosis, Aortic Stenosis Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Prolaio — Chicago

Identifiers

NCT: NCT07420907 · CTP-030

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗