Clinical trial NCT06378632: AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM
Official title: An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: Cordio Medical
Sponsor class: INDUSTRY
First posted: 2024-04-22
Enrollment: 500
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient clinics

Brief 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.

Detailed description: Two periods:

Run-In period will be a period in which patients will submit daily recordings, baseline creation

Core period will be a period in which patients will be followed up and will continually submit daily recordings for up-to 24 months per patient or until End-of-Study (EOS), whichever comes first.

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 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

Primary outcomes:
measure: Heart Failure Events (HFEs)
timeFrame: EOS is defined as when a total of at least 78 first usable and CEC-adjudicated HFEs have occurred or up-to 24 months per patient
Secondary outcomes:
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Eastern Shore Research Institute
state: Alabama
city: La Jolla
country: United States
facility: UC San Diego Health
state: California
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System
state: California
city: San Diego
country: United States
facility: VA San Diego
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco
state: California
city: Crystal River
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: Amavita Clinical Research
state: Florida
city: Miami
country: United States
facility: Advance Medical Research Services Corp (AMRS)
state: Florida
city: Miami
country: United States
facility: Baptist Health (Miami Cardiac & Vascular Institute)
state: Florida
city: Plantation
country: United States
facility: Comprehensive Medical & Research Center
state: Florida
city: St. Augustine
country: United States
facility: St. Johns Center for Clinical Research
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Carrollton
country: United States
facility: West Georgia Cardiology
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Chicago
country: United States
facility: Advocate Illinois Masonic Medical Center
state: Illinois
city: Downers Grove
country: United States
facility: Advocate Illinois Masonic Health Center
state: Illinois
city: Naperville
country: United States
facility: Midwest Cardiovascular Center
state: Illinois
city: Wichita
country: United States
facility: Robert J. Dole VA Medical Center
state: Kansas
city: Edgewood
country: United States
facility: St. Elizabeth Healthcare
state: Kentucky
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Lafayette
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: Lincoln
country: United States
facility: Nebraska Heart Center
state: Nebraska
city: North Las Vegas
country: United States
facility: VA Southern Nevada Healthcare System
state: Nevada
city: New York
country: United States
facility: Mount Sinai Morningside
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Research Center at The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: McAllen
country: United States
facility: Rio Grande Regional Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital of San Antonio
state: Texas
city: Ashdod
country: Israel
facility: University Hospital Samson Assuta Ashdod
city: Be'er Sheva
country: Israel
facility: Assuta Be'er Sheva Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Nahariya
country: Israel
facility: Galiee Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky (Ichilov) Medical Center
city: Tiberias
country: Israel
facility: Poriya Medical Center
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
Study officials:
affiliation: Cordio Medical
name: Ronit Haviv, PhD
role: STUDY_DIRECTOR
References: