AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM

Heart Failure Clinical Trial

— DETECT-HF  

Official title:

An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06378632
• Other study ID #: CLN0011 DETECT-HF
• Status: Recruiting
• Start date: February 11, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: Cordio Medical
• Contact: Bill Tobin
• Phone: (203) 852-8900
• Email: billt[@]ihcresearch.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Hearo App
No intervention - only data collection

Locations

Country	Name	City	State
Israel	University Hospital Samson Assuta Ashdod	Ashdod
Israel	Assuta Be'er Sheva Medical Center	Be'er Sheva
Israel	Rambam Medical Center	Haifa
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Galiee Medical Center	Nahariya
Israel	Tel Aviv Sourasky (Ichilov) Medical Center	Tel Aviv
Israel	Poriya Medical Center	Tiberias
United States	Mission Hospital	Asheville	North Carolina
United States	West Georgia Cardiology	Carrollton	Georgia
United States	Advocate Illinois Masonic Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	The Lindner Research Center at The Christ Hospital	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Nature Coast Clinical Research	Crystal River	Florida
United States	Advocate Illinois Masonic Health Center	Downers Grove	Illinois
United States	St. Elizabeth Healthcare	Edgewood	Kentucky
United States	Eastern Shore Research Institute	Fairhope	Alabama
United States	Moses H. Cone Memorial Hospital	Greensboro	North Carolina
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	UC San Diego Health	La Jolla	California
United States	Cardiovascular Institute of the South	Lafayette	Louisiana
United States	Nebraska Heart Center	Lincoln	Nebraska
United States	VA Loma Linda Healthcare System	Loma Linda	California
United States	Rio Grande Regional Hospital	McAllen	Texas
United States	Advance Medical Research Services Corp (AMRS)	Miami	Florida
United States	Amavita Clinical Research	Miami	Florida
United States	Baptist Health (Miami Cardiac & Vascular Institute)	Miami	Florida
United States	Midwest Cardiovascular Center	Naperville	Illinois
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	Mount Sinai Morningside	New York	New York
United States	The Mount Sinai Hospital	New York	New York
United States	VA Southern Nevada Healthcare System	North Las Vegas	Nevada
United States	Comprehensive Medical & Research Center	Plantation	Florida
United States	St. Francis Hospital	Roslyn	New York
United States	St. Johns Center for Clinical Research	Saint Augustine	Florida
United States	Methodist Hospital of San Antonio	San Antonio	Texas
United States	VA San Diego	San Diego	California
United States	Kaiser Permanente San Francisco	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	Tampa General Hospital	Tampa	Florida
United States	Robert J. Dole VA Medical Center	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Cordio Medical

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Failure Events (HFEs)	Until the end of the study, each participant will be assigned to one of the following event outcomes: Having at least one protocol-defined Heart Failure Event (HFE) in the CORE period; Having no Heart Failure Event (HFE) during the entire CORE period	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