RecruitingNCT06378632
AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM
An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System
Sponsor
Cordio Medical
Enrollment
500 participants
Start Date
Feb 11, 2022
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 22 Years
Inclusion Criteria9
- Age 22 or greater
- Diagnosed with Symptomatic Chronic Heart Failure \[NYHA II-IVa (ambulatory)\]
- At least one of the following:
- One ADHF hospitalization in the last 12 months
- One unplanned IV/SC diuretic administration in the last 6 months
- Two unplanned IV/SC diuretic administrations in the last 12 months
- NTProBNP \>500 pg/ml
- Clinically stable HF according to investigator discretion
- Willing to participate as evidenced by signing the written informed consent.
Exclusion Criteria6
- Unable to comply with daily use of the App,
- Has had a major cardiovascular event within 3 months prior to enrolment.
- Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
- Has estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73.
- Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
- Was treated for a significant COPD
Interventions
DEVICEHearo App
No intervention - only data collection
Locations(45)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06378632
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