AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM
Recruiting
Observational Study
Heart Failure
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 22 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 500 (estimated)
- Sponsor
- Cordio Medical · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 un…
Contacts