Actively Recruiting
An International Multi-center Observational Study to Assess the Performance of the Cordio HearO System in Heart Failure
Led by Cordio Medical · Updated on 2025-03-26
500
Participants Needed
45
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an international, multicenter, observational study to assess the performance of the Cordio HearO system in patients with symptomatic chronic heart failure. This non-interventional, prospective, single-arm study aims to collect patient voice recordings to analyze the sensitivity and unique patient noise reduction (UPNR) capabilities of the HearO device. The study is sponsored by Cordio Medical and focuses on monitoring heart failure events over time. The study consists of two periods: a Run-In period where patients submit daily recordings to establish a baseline, followed by a Core period where patients continue daily submissions for up to 24 months or until the study ends. There is no active treatment or intervention beyond data collection using the HearO app, which records patient utterances for later analysis. Participants will submit daily voice recordings throughout the study duration. Researchers will monitor heart failure events, defined as first usable and adjudicated heart failure events, as the primary outcome. The study involves regular data collection without additional interventions, focusing on patient adherence to daily use of the app. The total observation period per participant may last up to 24 months or until a predefined number of heart failure events have occurred.
CONDITIONS
Brief Title
AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 years or older
- Diagnosed with symptomatic chronic heart failure classified as NYHA II to IVa and ambulatory
- Has at least one of the following: one hospitalization for acute decompensated heart failure in the last 12 months, one unplanned intravenous or subcutaneous diuretic treatment in the last 6 months, two unplanned intravenous or subcutaneous diuretic treatments in the last 12 months, or NTProBNP level above 500 pg/ml
- Clinically stable heart failure as determined by the investigator
- Willingness to participate and sign informed consent
You will not qualify if you...
- Unable to comply with daily use of the HearO app
- Major cardiovascular event within 3 months prior to enrollment
- Cardiac resynchronization therapy device implanted or upgraded within 1 month prior to screening
- Estimated glomerular filtration rate less than 30 ml/min/1.73 m2
- Likely to undergo heart transplantation or left ventricular assist device within 6 months of screening
- Treated for significant chronic obstructive pulmonary disease (COPD)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Not specified
Participants will submit daily recordings using the Hearo app to create a baseline.
Daily recordings using the app
Duration - Up to 24 months
Participants are followed up and continually submit daily recordings for up to 24 months or until the end of the study.
Daily recordings using the app
Trial Site Locations
Total: 45 locations
1
Eastern Shore Research Institute
Fairhope, Alabama, United States, 36532
Actively Recruiting
2
UC San Diego Health
La Jolla, California, United States, 92037
Actively Recruiting
3
VA Loma Linda Healthcare System
Loma Linda, California, United States, 92357
Actively Recruiting
4
VA San Diego
San Diego, California, United States, 92161
Actively Recruiting
5
University of California, San Francisco
San Francisco, California, United States, 94117
Actively Recruiting
6
Kaiser Permanente San Francisco
San Francisco, California, United States, 94118
Actively Recruiting
7
Nature Coast Clinical Research
Crystal River, Florida, United States, 34429
Actively Recruiting
8
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Actively Recruiting
9
Amavita Clinical Research
Miami, Florida, United States, 33137
Actively Recruiting
10
Advance Medical Research Services Corp (AMRS)
Miami, Florida, United States, 33173
Actively Recruiting
11
Baptist Health (Miami Cardiac & Vascular Institute)
Miami, Florida, United States, 33173
Actively Recruiting
12
Comprehensive Medical & Research Center
Plantation, Florida, United States, 33317
Actively Recruiting
13
St. Johns Center for Clinical Research
Saint Augustine, Florida, United States, 32086
Actively Recruiting
14
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
15
West Georgia Cardiology
Carrollton, Georgia, United States, 30117
Actively Recruiting
16
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
17
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States, 60657
Actively Recruiting
18
Advocate Illinois Masonic Health Center
Downers Grove, Illinois, United States, 60515
Actively Recruiting
19
Midwest Cardiovascular Center
Naperville, Illinois, United States, 60540
Actively Recruiting
20
Robert J. Dole VA Medical Center
Wichita, Kansas, United States, 67218
Actively Recruiting
21
St. Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017
Actively Recruiting
22
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Actively Recruiting
23
Cardiovascular Institute of the South
Lafayette, Louisiana, United States, 70503
Actively Recruiting
24
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
25
Nebraska Heart Center
Lincoln, Nebraska, United States, 68526
Actively Recruiting
26
VA Southern Nevada Healthcare System
North Las Vegas, Nevada, United States, 89086
Actively Recruiting
27
Mount Sinai Morningside
New York, New York, United States, 10025
Actively Recruiting
28
The Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
29
St. Francis Hospital
Roslyn, New York, United States, 11576
Actively Recruiting
30
Mission Hospital
Asheville, North Carolina, United States, 28803
Actively Recruiting
31
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States, 27401
Actively Recruiting
32
The Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
33
Cleveland Clinic
Cleveland, Ohio, United States, 44106
Actively Recruiting
34
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
35
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
36
Rio Grande Regional Hospital
McAllen, Texas, United States, 78503
Actively Recruiting
37
Methodist Hospital of San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
38
University Hospital Samson Assuta Ashdod
Ashdod, Israel
Actively Recruiting
39
Assuta Be'er Sheva Medical Center
Beersheba, Israel
Actively Recruiting
40
Rambam Medical Center
Haifa, Israel
Actively Recruiting
41
Shaare Zedek Medical Center
Jerusalem, Israel
Actively Recruiting
42
Galiee Medical Center
Nahariya, Israel
Actively Recruiting
43
Tel Aviv Sourasky (Ichilov) Medical Center
Tel Aviv, Israel
Actively Recruiting
44
Poriya Medical Center
Tiberias, Israel
Actively Recruiting
45
Hospital Universitari Germans Trias i Pujol
Badalona, Spain, 08916
Actively Recruiting
Research Team
B
Bill Tobin
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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