RecruitingNCT06378632

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

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

Sponsor

Cordio Medical

Enrollment

500 participants

Start Date

Feb 11, 2022

Study Type

OBSERVATIONAL

Conditions

Heart Failure

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.

Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a voice monitoring system called Cordio HeaRO, which uses a smartphone app to detect early signs of worsening heart failure by analyzing subtle changes in a patient's voice — potentially enabling earlier intervention before hospitalization. **You may be eligible if...** - You are 22 or older - You have been diagnosed with symptomatic chronic heart failure (NYHA class II to IVa — meaning you have noticeable symptoms during activity or even at rest but are still able to walk) - You meet at least one of the following: a hospitalization for acute heart failure in the last year, an emergency IV diuretic (water pill) treatment in the last 6 months, two emergency diuretic treatments in the last year, or elevated NTproBNP levels (above 500 pg/ml) - Your heart failure is currently stable - You are willing and able to use the app daily **You may NOT be eligible if...** - You had a major cardiovascular event (like a heart attack) within the past 3 months - You recently had a cardiac resynchronization device (CRT) implanted (within 1 month) - You are unable to comply with daily app use Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHearo App

No intervention - only data collection

Locations(45)

Eastern Shore Research Institute

Fairhope, Alabama, United States

UC San Diego Health

La Jolla, California, United States

VA Loma Linda Healthcare System

Loma Linda, California, United States

VA San Diego

San Diego, California, United States

University of California, San Francisco

San Francisco, California, United States

Kaiser Permanente San Francisco

San Francisco, California, United States

Nature Coast Clinical Research

Crystal River, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Amavita Clinical Research

Miami, Florida, United States

Advance Medical Research Services Corp (AMRS)

Miami, Florida, United States

Baptist Health (Miami Cardiac & Vascular Institute)

Miami, Florida, United States

Comprehensive Medical & Research Center

Plantation, Florida, United States

St. Johns Center for Clinical Research

Saint Augustine, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

West Georgia Cardiology

Carrollton, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States

Advocate Illinois Masonic Health Center

Downers Grove, Illinois, United States

Midwest Cardiovascular Center

Naperville, Illinois, United States

Robert J. Dole VA Medical Center

Wichita, Kansas, United States

St. Elizabeth Healthcare

Edgewood, Kentucky, United States

Cardiovascular Institute of the South

Houma, Louisiana, United States

Cardiovascular Institute of the South

Lafayette, Louisiana, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Nebraska Heart Center

Lincoln, Nebraska, United States

VA Southern Nevada Healthcare System

North Las Vegas, Nevada, United States

Mount Sinai Morningside

New York, New York, United States

The Mount Sinai Hospital

New York, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Mission Hospital

Asheville, North Carolina, United States

Moses H. Cone Memorial Hospital

Greensboro, North Carolina, 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

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Rio Grande Regional Hospital

McAllen, Texas, United States

Methodist Hospital of San Antonio

San Antonio, Texas, 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, Spain

View Full Details on ClinicalTrials.gov

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