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NCT06378632Recruiting

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

Cordio Medical

Start Date

2/11/2022

Completion Date

7/15/2025

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

Age Range: 22 years to No maximum

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

Interventions

DEVICE

Hearo App

Interested in This Trial?

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Conditions

Heart Failure

Locations

Eastern Shore Research Institute

Fairhope, Alabama 36532

United States

UC San Diego Health

La Jolla, California 92037

United States

VA Loma Linda Healthcare System

Loma Linda, California 92357

United States

VA San Diego

San Diego, California 92161

United States

University of California, San Francisco

San Francisco, California 94117

United States

Kaiser Permanente San Francisco

San Francisco, California 94118

United States

Nature Coast Clinical Research

Crystal River, Florida 34429

United States

Jacksonville Center for Clinical Research

Jacksonville, Florida 32216

United States

Amavita Clinical Research

Miami, Florida 33137

United States

Advance Medical Research Services Corp (AMRS)

Miami, Florida 33173

United States

Baptist Health (Miami Cardiac & Vascular Institute)

Miami, Florida 33173

United States

Comprehensive Medical & Research Center

Plantation, Florida 33317

United States

St. Johns Center for Clinical Research

Saint Augustine, Florida 32086

United States

Tampa General Hospital

Tampa, Florida 33606

United States

West Georgia Cardiology

Carrollton, Georgia 30117

United States

University of Chicago

Chicago, Illinois 60637

United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois 60657

United States

Advocate Illinois Masonic Health Center

Downers Grove, Illinois 60515

United States

Midwest Cardiovascular Center

Naperville, Illinois 60540

United States

Robert J. Dole VA Medical Center

Wichita, Kansas 67218

United States

St. Elizabeth Healthcare

Edgewood, Kentucky 41017

United States

Cardiovascular Institute of the South

Houma, Louisiana 70360

United States

Cardiovascular Institute of the South

Lafayette, Louisiana 70503

United States

University Medical Center New Orleans

New Orleans, Louisiana 70112

United States

Nebraska Heart Center

Lincoln, Nebraska 68526

United States

VA Southern Nevada Healthcare System

North Las Vegas, Nevada 89086

United States

Mount Sinai Morningside

New York, New York 10025

United States

The Mount Sinai Hospital

New York, New York 10029

United States

St. Francis Hospital

Roslyn, New York 11576

United States

Mission Hospital

Asheville, North Carolina 28803

United States

Moses H. Cone Memorial Hospital

Greensboro, North Carolina 27401

United States

The Lindner Research Center at The Christ Hospital

Cincinnati, Ohio 45219

United States

Cleveland Clinic

Cleveland, Ohio 44106

United States

The Ohio State University

Columbus, Ohio 43210

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Rio Grande Regional Hospital

McAllen, Texas 78503

United States

Methodist Hospital of San Antonio

San Antonio, Texas 78229

United States

University Hospital Samson Assuta Ashdod

Ashdod,

Israel

Assuta Be'er Sheva Medical Center

Beersheba,

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,

Israel

Hospital Universitari Germans Trias i Pujol

Badalona, 08916

Spain