Clinical trial NCT05876533: R&D Study to Evaluate Cordio's Usability and to Collect Patient Speech Utterances
Official title: An Observational, Retrospective, Single-arm, Open US and Israel Study , for Usability Assessment and Algorithm, Development of the Cordio HearO™ Systeam
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Heart Failure
Keywords: CHF
Lead sponsor: Cordio Medical
Sponsor class: INDUSTRY
First posted: 2023-05-25
Enrollment: 216
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult clinical stable patients with NYHA II-IVa (ambulatory)

Brief summary: To determine the usability and technical aspects of Cordio HearO™

Detailed description: The system (including App and server) will be tested under simulated use conditions with representative users to identify potential changes required to the application user interface, to improve user performance and satisfaction, and to inform future design options.

The recordings data will also be used for algorithm improvement

Eligibility criteria: Major inclusion Criteria:

1. Adults patients
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).

Major exclusion Criteria:

1. Not able to read in Hebrew, Russian, Arabic, English and/or Spanish.
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.

Primary outcomes:
measure: Patient Usability success defined as: 1.Total and individual usability score of ≥3 in the usability questionnaire in ≥80% of the users.
timeFrame: 2 years
measure: Patient Usability success defined as: 2. Total Compliance
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: South Windsor
country: United States
facility: Kurker Family Medicine
state: Connecticut
city: Cape Coral
country: United States
facility: C&R Research Services
state: Florida
city: Miami
country: United States
facility: C&R Research Services
state: Florida
city: Miami
country: United States
facility: C&R Research Services
state: Florida
city: Athens
country: United States
facility: Lake County Med Grp
state: Georgia
city: Ashkelon
country: Israel
facility: Barzilai Medical Center- Cardiology
city: Be'er Sheva
country: Israel
facility: Heart Failure Clinic - Clallit Be'er Sheva
city: Petah tikva
country: Israel
facility: Rabin Medical Center - Cardiology- CHF
Study officials:
affiliation: Cordio Medical
name: Ronit Haviv, PhD
role: STUDY_DIRECTOR
References: