AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM
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
Interventions
Hearo App
Conditions
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