The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05646056
Recruitment Status : **RECRUITING NOW**
First Posted : December 12, 2022
Last Update Posted : December 12, 2022
Sponsor:
Information provided by (Responsible Party):
Prolaio
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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.
Heart Failure Cardiomyopathy, Hypertrophic Left Ventricular Hypertrophy
Device: Software
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Study Type :
Observational
Estimated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Noninterventional, Single-Center Feasibility Study to Evaluate Longitudinal Measures of Heart Failure Risk Using the Pyxida System
Actual Study Start Date :
October 28, 2022
Estimated Primary Completion Date :
March 31, 2023
Estimated Study Completion Date :
March 31, 2024
Resource links provided by the National Library of Medicine
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Healthy subjects
Device: Software
Observation only
Asymptomatic left ventricular hypertrophy
Device: Software
Observation only
Asymptomatic subjects with a history of HF
Device: Software
Observation only
Subjects with a history of hypertrophic cardiomyopathy NYHA Class I, II
Device: Software
Observation only
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Primary Outcome Measures :
Percentage of complete daily datasets transmitted to the Pyxida System database at the end of the monitoring period [ Time Frame: 14 days ]
Secondary Outcome Measures :
To evaluate subject compliance and experience using the Pyxida System [ Time Frame: 14 days ]
Other Outcome Measures:
To evaluate the relationship between in-clinic and ambulatory measures using the Pyxida System [ Time Frame: 14 days ]
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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Ages Eligible for Study: Â
18 Years and older  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Sampling Method: Â
Probability Sample
asymptomatic healthy subjects and subjects with heart failure risk factors and no or moderate symptoms
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
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05646056
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Contact: Jay Edelberg, MD PhD
650 646 5609
info@prolaio.com
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Research Center
Jacksonville, Florida, United States, 32216
Prolaio
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Principal Investigator:
Michael Koren, MD
Jacksonville Center For Clinical Research
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Responsible Party:
Prolaio
ClinicalTrials.gov Identifier:
NCT05646056 Â Â
Other Study ID Numbers:
PRO-001-001
First Posted:
December 12, 2022 Â Â Key Record Dates
Last Update Posted:
December 12, 2022
Last Verified:
November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Undecided
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
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Cardiovascular DiseasesHeart FailureCardiomyopathiesHypertrophy, Left VentricularCardiomyopathy, HypertrophicHypertrophyHeart Diseases
Pathological Conditions, AnatomicalCardiomegalyAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
