NCT05646056
Completed
Not Applicable
A Noninterventional, Single-Center Feasibility Study to Evaluate Longitudinal Measures of Heart Failure Risk Using the Pyxida System
Prolaio1 site in 1 country82 target enrollmentOctober 28, 2022
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Prolaio
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- To evaluate the ability of the Pyxida System to collect measurements of heart failure (HF) risk
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
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
- To evaluate subject compliance and experience using the Pyxida System(14 days)
Study Sites (1)
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