R&D Study to Evaluate Cordio's Usability and to Collect Patient Speech Utterances
NCT ID: NCT05876533
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
216 participants
OBSERVATIONAL
2022-03-18
2025-03-15
Brief Summary
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Detailed Description
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The recordings data will also be used for algorithm improvement
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Cordio HearO
Cordio HearO is a software medical device that remotely monitors Congestive Heart Failure (CHF) patients by detecting changes in the patients' recorded voice relative to a baseline. The system is comprised of a mobile application (or "app") that is deployed on a mobile platform, and a web-based portal that enables caregivers to manage their patients
Eligibility Criteria
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Inclusion Criteria
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 administration in the last 12 months
4. NTProBNP \>500 pg/ml or BNP\*\> 150 pg/ml at screening visit
4. Clinically stable HF
5. Willing to participate as evidenced by signing the written informed consent.
6. Male or non-pregnant female patient (pre-menopausal women will confirm verbally).
Exclusion Criteria
2. Unable to comply with daily use of the App
3. Major cardiovascular event
4. Had a Cardiac Resynchronization Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
5. Has estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73 meter square (Cockroft-Gault formula).
6. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
22 Years
ALL
No
Sponsors
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Cordio Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Ronit Haviv, PhD
Role: STUDY_DIRECTOR
Cordio Medical
Locations
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Kurker Family Medicine
South Windsor, Connecticut, United States
C&R Research Services
Cape Coral, Florida, United States
C&R Research Services
Miami, Florida, United States
C&R Research Services
Miami, Florida, United States
Lake County Med Grp
Athens, Georgia, United States
Barzilai Medical Center- Cardiology
Ashkelon, , Israel
Heart Failure Clinic - Clallit Be'er Sheva
Beersheba, , Israel
Rabin Medical Center - Cardiology- CHF
Petah Tikva, , Israel
Countries
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Other Identifiers
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CLN0016
Identifier Type: -
Identifier Source: org_study_id