Heart Failure Clinical Trial
Official title:
A Noninterventional, Single-Center Feasibility Study to Evaluate Longitudinal Measures of Heart Failure Risk Using the Pyxida System
Verified date | November 2022 |
Source | Prolaio |
Contact | Jay Edelberg, MD PhD |
Phone | 650 646 5609 |
info[@]prolaio.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 31, 2024 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Research Center | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Prolaio |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To evaluate the relationship between in-clinic and ambulatory measures using the Pyxida System | 14 days | ||
Primary | Percentage of complete daily datasets transmitted to the Pyxida System database at the end of the monitoring period | 14 days | ||
Secondary | To evaluate subject compliance and experience using the Pyxida System | 14 days |
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