AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM

a study on Heart Failure

Summary

Eligibility
for people ages 22 years and up (full criteria)
Location
at UCSD UCSF
Dates
study started
completion around
Principal Investigator
by Nicholas Wettersten, MD (ucsd)Liviu Klein, MD (ucsf)
Headshot of Nicholas Wettersten
Nicholas Wettersten
Headshot of Liviu Klein
Liviu Klein

Description

Summary

Study Design:

This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system.

Official Title

An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System

Details

Two periods:

Run-In period will be a period in which patients will submit daily recordings, baseline creation

Core period will be a period in which patients will be followed up and will continually submit daily recordings for up-to 24 months per patient or until End-of-Study (EOS), whichever comes first.

Keywords

Heart Failure, Hearo App

Eligibility

For people ages 22 years and up

Major Inclusion Criteria:

  1. Age 22 or greater
  2. Diagnosed with Symptomatic Chronic Heart Failure [NYHA II-IVa (ambulatory)]
  3. At least one of the following:
    1. One ADHF hospitalization in the last 12 months
    2. One unplanned IV/SC diuretic administration in the last 6 months
    3. Two unplanned IV/SC diuretic administrations in the last 12 months
    4. NTProBNP >500 pg/ml
  4. Clinically stable HF according to investigator discretion
  5. Willing to participate as evidenced by signing the written informed consent.

Major Exclusion Criteria:

  1. Unable to comply with daily use of the App,
  2. Has had a major cardiovascular event within 3 months prior to enrolment.
  3. Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
  4. Has estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73.
  5. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
  6. Was treated for a significant COPD

Locations

  • UC San Diego Health accepting new patients
    La Jolla California 92037 United States
  • University of California, San Francisco accepting new patients
    San Francisco California 94117 United States
  • VA San Diego accepting new patients
    San Diego California 92161 United States
  • Kaiser Permanente San Francisco accepting new patients
    San Francisco California 94118 United States

Lead Scientists at University of California Health

  • Nicholas Wettersten, MD (ucsd)
    Associate Professor Of Clinical, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 54 research publications. Research interests: Biomarkers · Heart Failure · Kidney Disease · Cardiorenal Syndrome
  • Liviu Klein, MD (ucsf)
    My are heart failure and cardiac arrhythmias in patients with heart failure. Having advanced training in both heart failure and electrophysiology, I practice an integrated approach in treating patients with heart failure and cardiac arrhythmias. I am also interested in cardiac recovery using electrical (i.e. cardiac resynchronization) and mechanical (i.e. ventricular assist devices) therapies.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cordio Medical
ID
NCT06378632
Study Type
Observational
Participants
Expecting 500 study participants
Last Updated