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Evaluating Infrasonic Hemodynography
This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system.
Conditions:
🦠 Aortic Stenosis 🦠 Mitral Regurgitation 🦠 Pulmonary Hypertension 🦠 Heart Failure, Systolic 🦠 Cardiovascular Diseases 🦠 Coronary Artery Disease
🗓️ Study Start (Actual) 4 January 2021
🗓️ Primary Completion (Estimated) 1 December 2025
✅ Study Completion (Estimated) 1 December 2025
👥 Enrollment (Estimated) 25
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 La Jolla, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Normal Sinus Rhythm
    • * LV systolic function \>53%

    Exclusion Criteria:

    • * 1. Known history of carotid artery disease
    • * 2. Moderate or greater valvular disease in Group 1
    • * 3. Other implantable devices (pacemaker, ICD, CardioMems, TENS unit, continuous glucose monitors, etc)
    • * 4. Active arrhythmia
    • * 5. Reduced Ejection Fraction (\< 35%) other than Group 4
    • * 6. Hearing loss
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 November 2020
  • First Submitted that Met QC Criteria 15 November 2020
  • First Posted 19 November 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 April 2024
  • Last Update Posted 16 April 2024
  • Last Verified April 2024
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