AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM
DETECT-HF
An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System
Sponsor study identifier
observational
500
3 countries
45
Study Start
February 11, 2022
Actual (reported)Primary Completion
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 11, 2022
Actual (reported)April 14, 2024
Actual (reported)April 22, 2024
Actual (reported)July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Heart Failure Events (HFEs)
Until the end of the study, each participant will be assigned to one of the following event outcomes: 1. Having at least one protocol-defined Heart Failure Event (HFE) in the CORE period 2. 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
No intervention - only data collection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Outpatient clinics
Eastern Shore Research Institute
Fairhope, Alabama, 36532, United States
UC San Diego Health
La Jolla, California, 92037, United States
Ronit Haviv, PhD
Cordio Medical
First Submitted
April 14, 2024
First Posted
April 22, 2024
Study Start
February 11, 2022
Actual (reported)Primary Completion
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Registry of Patients with Suspected Amyloidosis in Heart Failure
Contact the study team to confirm eligibility.
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
Study Completion
July 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 26, 2025
Record last verified: 2025-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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