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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05646056

Enrollment

Registered

2022-12-12

Start date

2022-10-28

Completion date

2024-09-18

Last updated

2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Cardiomyopathy, Hypertrophic, Left Ventricular Hypertrophy

Brief summary

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.

Interventions

DEVICESoftware

Observation only

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the ability of the Pyxida System to collect measurements of heart failure (HF) risk	14 days	Percentage of complete daily datasets transmitted to the Pyxida System database at the end of the monitoring period

Secondary

Measure	Time frame	Description
To evaluate subject compliance and experience using the Pyxida System	14 days	Outcomes of subject post-study survey

Other

Measure	Time frame	Description
To evaluate the relationship between in-clinic and ambulatory measures using the Pyxida System	14 days	Correlation between in-clinic 6-minute walk test (6MWT) measures of exercise tolerance and ambulatory electrocardiogram (ECG)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026