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

Description

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.

Conditions

Heart Failure

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

Fairhope

Eastern Shore Research Institute, Fairhope, Alabama, United States, 36532

La Jolla

UC San Diego Health, La Jolla, California, United States, 92037

Loma Linda

VA Loma Linda Healthcare System, Loma Linda, California, United States, 92357

San Diego

VA San Diego, San Diego, California, United States, 92161

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94117

San Francisco

Kaiser Permanente San Francisco, San Francisco, California, United States, 94118

Crystal River

Nature Coast Clinical Research, Crystal River, Florida, United States, 34429

Jacksonville

Jacksonville Center for Clinical Research, Jacksonville, Florida, United States, 32216

Miami

Amavita Clinical Research, Miami, Florida, United States, 33137

Miami

Advance Medical Research Services Corp (AMRS), Miami, Florida, United States, 33173

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cordio Medical,

Ronit Haviv, PhD, STUDY_DIRECTOR, Cordio Medical

Study Record Dates

2024-12-01