🔎 Trials Near Me

Home › Heart Failure › NCT06378632

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

RecruitingObservational study

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

Who can join

Ages 22 and older · All sexes

Full eligibility criteria
Major Inclusion Criteria:

1. Age 22 or greater
2. Diagnosed with Symptomatic Chronic Heart Failure \[NYHA II-IVa (ambulatory)\]
3. At least one of the following:

   1. One ADHF hospitalization in the last 12 months
   2. One unplanned IV/SC diuretic administration in the last 6 months
   3. Two unplanned IV/SC diuretic administrations in the last 12 months
   4. NTProBNP \>500 pg/ml
4. Clinically stable HF according to investigator discretion
5. Willing to participate as evidenced by signing the written informed consent.

Major Exclusion Criteria:

1. Unable to comply with daily use of the App,
2. Has had a major cardiovascular event within 3 months prior to enrolment.
3. Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
4. Has estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73.
5. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
6. Was treated for a significant COPD

About the study

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.

What is being tested

Sponsor: Cordio Medical · Participants: 500 · Started: Feb 11, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT06378632

Locations in the U.S.

AlabamaEastern Shore Research Institute, Fairhope
CaliforniaUC San Diego Health, La Jolla
VA Loma Linda Healthcare System, Loma Linda
VA San Diego, San Diego
Kaiser Permanente San Francisco, San Francisco
University of California, San Francisco, San Francisco
FloridaNature Coast Clinical Research, Crystal River
Jacksonville Center for Clinical Research, Jacksonville
Advance Medical Research Services Corp (AMRS), Miami
Amavita Clinical Research, Miami
Baptist Health (Miami Cardiac & Vascular Institute), Miami
Comprehensive Medical & Research Center, Plantation
St. Johns Center for Clinical Research, Saint Augustine
Tampa General Hospital, Tampa
GeorgiaWest Georgia Cardiology, Carrollton
IllinoisAdvocate Illinois Masonic Medical Center, Chicago
University of Chicago, Chicago
Advocate Illinois Masonic Health Center, Downers Grove
Midwest Cardiovascular Center, Naperville
KansasRobert J. Dole VA Medical Center, Wichita
KentuckySt. Elizabeth Healthcare, Edgewood
LouisianaCardiovascular Institute of the South, Houma
Cardiovascular Institute of the South, Lafayette
University Medical Center New Orleans, New Orleans
NebraskaNebraska Heart Center, Lincoln
NevadaVA Southern Nevada Healthcare System, North Las Vegas
New YorkMount Sinai Morningside, New York
The Mount Sinai Hospital, New York
St. Francis Hospital, Roslyn
North CarolinaMission Hospital, Asheville
Moses H. Cone Memorial Hospital, Greensboro
OhioThe Lindner Research Center at The Christ Hospital, Cincinnati
Cleveland Clinic, Cleveland
The Ohio State University, Columbus
TennesseeVanderbilt University Medical Center, Nashville
TexasRio Grande Regional Hospital, McAllen
Methodist Hospital of San Antonio, San Antonio

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.