An INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY to ASSESS the PERFORMANCE of the CORDIO HEARO SYSTEM

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT06378632
• Lead Sponsor: Cordio Medical

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-02-11
• Study First Submitted: 2024-04-14
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart Failure Events (HFEs)	EOS is defined as when a total of at least 78 first usable and CEC-adjudicated HFEs have occurred or up-to 24 months per patient	Until the end of the study, each participant will be assigned to one of the following event outcomes: 1. Having at least one protocol-defined Heart Failure Event (HFE) in the CORE period; 2. Having no Heart Failure Event (HFE) during the entire CORE period

Trial Locations

Locations (44)

Eastern Shore Research Institute; 🇺🇸 Fairhope, Alabama, United States

UC San Diego Health; 🇺🇸 La Jolla, California, United States

VA Loma Linda Healthcare System; 🇺🇸 Loma Linda, California, United States

VA San Diego; 🇺🇸 San Diego, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Kaiser Permanente San Francisco; 🇺🇸 San Francisco, California, United States

Nature Coast Clinical Research; 🇺🇸 Crystal River, Florida, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Amavita Clinical Research; 🇺🇸 Miami, Florida, United States

Advance Medical Research Services Corp (AMRS); 🇺🇸 Miami, Florida, United States

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