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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05646056
Other study ID # PRO-001-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 28, 2022
Est. completion date March 31, 2024

Study information

Verified date November 2022
Source Prolaio
Contact Jay Edelberg, MD PhD
Phone 650 646 5609
Email info@prolaio.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Software
Observation only

Locations

Country Name City State
United States Research Center Jacksonville Florida

Sponsors (1)

Lead Sponsor Collaborator
Prolaio

Country where clinical trial is conducted

United States, 

Outcome

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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