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

NCT06378632 · tracked via the Priya Life Science USA tracker

Sponsor

Cordio Medical

Phase

Observational

Started

2022-02-11

Last updated

2025-03-26

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Hearo App

Hearo App: No intervention - only data collection

Study 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.

Eligibility

Sex

ALL

Min age

22 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Heart Failure Events (HFEs) — 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
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

Trial sites (45)

Facility	City	Region	Status
Eastern Shore Research Institute	Fairhope	Alabama	Recruiting
UC San Diego Health	La Jolla	California	Recruiting
VA Loma Linda Healthcare System	Loma Linda	California	Recruiting
VA San Diego	San Diego	California	Recruiting
University of California, San Francisco	San Francisco	California	Recruiting
Kaiser Permanente San Francisco	San Francisco	California	Recruiting
Nature Coast Clinical Research	Crystal River	Florida	Recruiting
Jacksonville Center for Clinical Research	Jacksonville	Florida	Recruiting
Amavita Clinical Research	Miami	Florida	Recruiting
Advance Medical Research Services Corp (AMRS)	Miami	Florida	Recruiting
Baptist Health (Miami Cardiac & Vascular Institute)	Miami	Florida	Recruiting
Comprehensive Medical & Research Center	Plantation	Florida	Recruiting
St. Johns Center for Clinical Research	Saint Augustine	Florida	Recruiting
Tampa General Hospital	Tampa	Florida	Recruiting
West Georgia Cardiology	Carrollton	Georgia	Recruiting
University of Chicago	Chicago	Illinois	Recruiting
Advocate Illinois Masonic Medical Center	Chicago	Illinois	Recruiting
Advocate Illinois Masonic Health Center	Downers Grove	Illinois	Recruiting
Midwest Cardiovascular Center	Naperville	Illinois	Recruiting
Robert J. Dole VA Medical Center	Wichita	Kansas	Recruiting
St. Elizabeth Healthcare	Edgewood	Kentucky	Recruiting
Cardiovascular Institute of the South	Houma	Louisiana	Recruiting
Cardiovascular Institute of the South	Lafayette	Louisiana	Recruiting
University Medical Center New Orleans	New Orleans	Louisiana	Recruiting
Nebraska Heart Center	Lincoln	Nebraska	Recruiting
VA Southern Nevada Healthcare System	North Las Vegas	Nevada	Recruiting
Mount Sinai Morningside	New York	New York	Recruiting
The Mount Sinai Hospital	New York	New York	Recruiting
St. Francis Hospital	Roslyn	New York	Recruiting
Mission Hospital	Asheville	North Carolina	Recruiting
Moses H. Cone Memorial Hospital	Greensboro	North Carolina	Recruiting
The Lindner Research Center at The Christ Hospital	Cincinnati	Ohio	Recruiting
Cleveland Clinic	Cleveland	Ohio	Recruiting
The Ohio State University	Columbus	Ohio	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	Recruiting
Rio Grande Regional Hospital	McAllen	Texas	Recruiting
Methodist Hospital of San Antonio	San Antonio	Texas	Recruiting
University Hospital Samson Assuta Ashdod	Ashdod	Israel	Recruiting
Assuta Be'er Sheva Medical Center	Beersheba	Israel	Recruiting
Rambam Medical Center	Haifa	Israel	Recruiting

+ 5 more sites — see the full list on the official registry below.

More Cordio Medical trials in the USA

R&D Study to Evaluate Cordio's Usability and to Collect Patient Speech Utterances Active, not recruiting

Other trials for the same condition

Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study) Enrolling by invitation

Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients Active, not recruiting

MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure Recruiting

Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting

XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06378632 on ClinicalTrials.gov ↗ ← All trials in the USA