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RECRUITING
NCT06378632

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

Sponsor: Cordio Medical

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2022-02-11

Completion Date

2025-07-15

Last Updated

2025-03-26

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Hearo 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