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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearo App | Device | No intervention - only data collection |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Failure Events (HFEs) | Until the end of the study, each participant will be assigned to one of the following event outcomes:
| 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 |
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Major Inclusion Criteria:
Age 22 or greater
Diagnosed with Symptomatic Chronic Heart Failure [NYHA II-IVa (ambulatory)]
At least one of the following:
Clinically stable HF according to investigator discretion
Willing to participate as evidenced by signing the written informed consent.
Major Exclusion Criteria:
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Outpatient clinics
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bill Tobin | Contact | (203) 852-8900 | billt@ihcresearch.com |
| Name | Affiliation | Role |
|---|---|---|
| Ronit Haviv, PhD | Cordio Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Shore Research Institute | Recruiting | Fairhope | Alabama | 36532 | United States |
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| UC San Diego Health | Recruiting | La Jolla | California | 92037 | United States |
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| VA Loma Linda Healthcare System | Recruiting | Loma Linda | California | 92357 | United States |
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| VA San Diego | Recruiting | San Diego | California | 92161 | United States |
|
| University of California, San Francisco | Recruiting | San Francisco | California | 94117 | United States |
|
| Kaiser Permanente San Francisco | Recruiting | San Francisco | California | 94118 | United States |
|
| Nature Coast Clinical Research | Recruiting | Crystal River | Florida | 34429 | United States |
|
| Jacksonville Center for Clinical Research | Recruiting | Jacksonville | Florida | 32216 | United States |
|
| Amavita Clinical Research | Recruiting | Miami | Florida | 33137 | United States |
|
| Advance Medical Research Services Corp (AMRS) | Recruiting | Miami | Florida | 33173 | United States |
|
| Baptist Health (Miami Cardiac & Vascular Institute) | Recruiting | Miami | Florida | 33173 | United States |
|
| Comprehensive Medical & Research Center | Recruiting | Plantation | Florida | 33317 | United States |
|
| St. Johns Center for Clinical Research | Recruiting | Saint Augustine | Florida | 32086 | United States |
|
| Tampa General Hospital | Recruiting | Tampa | Florida | 33606 | United States |
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| West Georgia Cardiology | Recruiting | Carrollton | Georgia | 30117 | United States |
|
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| Advocate Illinois Masonic Medical Center | Recruiting | Chicago | Illinois | 60657 | United States |
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| Advocate Illinois Masonic Health Center | Recruiting | Downers Grove | Illinois | 60515 | United States |
|
| Midwest Cardiovascular Center | Recruiting | Naperville | Illinois | 60540 | United States |
|
| Robert J. Dole VA Medical Center | Recruiting | Wichita | Kansas | 67218 | United States |
|
| St. Elizabeth Healthcare | Recruiting | Edgewood | Kentucky | 41017 | United States |
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| Cardiovascular Institute of the South | Recruiting | Houma | Louisiana | 70360 | United States |
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| Cardiovascular Institute of the South | Recruiting | Lafayette | Louisiana | 70503 | United States |
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| University Medical Center New Orleans | Recruiting | New Orleans | Louisiana | 70112 | United States |
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| Nebraska Heart Center | Recruiting | Lincoln | Nebraska | 68526 | United States |
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| VA Southern Nevada Healthcare System | Recruiting | North Las Vegas | Nevada | 89086 | United States |
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| Mount Sinai Morningside | Recruiting | New York | New York | 10025 | United States |
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| The Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
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| St. Francis Hospital | Recruiting | Roslyn | New York | 11576 | United States |
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| Mission Hospital | Recruiting | Asheville | North Carolina | 28803 | United States |
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| Moses H. Cone Memorial Hospital | Recruiting | Greensboro | North Carolina | 27401 | United States |
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| The Lindner Research Center at The Christ Hospital | Recruiting | Cincinnati | Ohio | 45219 | United States |
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| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44106 | United States |
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| The Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Rio Grande Regional Hospital | Recruiting | McAllen | Texas | 78503 | United States |
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| Methodist Hospital of San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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| University Hospital Samson Assuta Ashdod | Recruiting | Ashdod | Israel |
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| Assuta Be'er Sheva Medical Center | Recruiting | Beersheba | Israel |
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| Rambam Medical Center | Recruiting | Haifa | Israel |
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| Shaare Zedek Medical Center | Recruiting | Jerusalem | Israel |
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| Galiee Medical Center | Recruiting | Nahariya | Israel |
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| Tel Aviv Sourasky (Ichilov) Medical Center | Recruiting | Tel Aviv | Israel |
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| Poriya Medical Center | Recruiting | Tiberias | Israel |
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| Hospital Universitari Germans Trias i Pujol | Recruiting | Badalona | 08916 | Spain |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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