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

ID#: NCT06378632

Age: 22 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: February 11, 2022

End Date: December 01, 2024

Contact Information:
Bill Tobin
(203) 852-8900
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.
Eligibility: 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
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