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Completed

NCT Number: NCT05646056

A Noninterventional, Single-Center Feasibility Study to Evaluate Measures of Heart Failure Risk

This is a non-invasive/observational study in healthy and mild HF subjects utilizing clinical and ambulatory measurements to improve detection, monitoring, and management of HF risks.

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Key information

Conditions

Heart Failure Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomegaly Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases Hypertrophy Hypertrophy, Left Ventricular Left Ventricular Hypertrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Who can participate

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

Key Inclusion Criteria:

  • Cohort 2: Confirmed medical history of LVH based on American College of Cardiology (ACC)/American Heart Association (AHA) guidelines and NYHA Class I at screening
  • Cohort 3: Confirmed medical history of HF consistent with current ACC/AHA guidelines and NYHA Class I at screening
  • Cohort 4: Confirmed medical history of HCM consistent with ACC/AHA guidelines and NYHA Class I or II at screening

Key Exclusion Criteria:

  • Active neurological disorder, such as uncontrolled seizure disorder.
  • Current diagnosis of cancer or other known acute chronic infection, such as hepatitis B or hepatitis C, by medical history or an active infection requiring interventional therapy at screening.
  • Shortness of breath, fatigue, heart palpitations, pain, or other limitations of physical activity

Treatment and study plan

software

Device

Observation only

Primary outcomes

  1. To evaluate the ability of the Pyxida System to collect measurements of heart failure (HF) risk

    Time frame: 14 days

    Percentage of complete daily datasets transmitted to the Pyxida System database at the end of the monitoring period

Secondary outcomes

  1. To evaluate subject compliance and experience using the Pyxida System

    Time frame: 14 days

    Outcomes of subject post-study survey

Other outcomes

  1. To evaluate the relationship between in-clinic and ambulatory measures using the Pyxida System

    Time frame: 14 days

    Correlation between in-clinic 6-minute walk test (6MWT) measures of exercise tolerance and ambulatory electrocardiogram (ECG)

Sponsors and collaborators

Lead sponsor

Prolaio

Industry

Registry information

Official study title

A Noninterventional, Single-Center Feasibility Study to Evaluate Longitudinal Measures of Heart Failure Risk Using the Pyxida System

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 12, 2022
Registry last updated
Oct 24, 2024

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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