Recruiting

Observational Study

Sponsor:

Cordio Medical

Code:

NCT06378632

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Hearo App

Study Details

Brief 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.

Conditions

Heart Failure

Study ID

NCT06378632

Start date

Feb 11, 2022

Status verified date

Mar, 2025

Completion date

Jul 15, 2025

Anticipated

Primary completion date

Jul 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Interventions

Hearo App

No intervention - only data collection

Primary outcome measure

  • Heart Failure Events (HFEs) [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Locations

Eastern Shore Research Institute

Recruiting

Fairhope, Alabama, United States, 36532

Contacts

Principal Investigator:

Michael Pursley, MD

UC San Diego Health

Recruiting

La Jolla, California, United States, 92037

Contacts

Principal Investigator:

Nicholas Wettersten, MD

VA Loma Linda Healthcare System

Recruiting

Loma Linda, California, United States, 92357

Contacts

Principal Investigator:

Jay Patel, MD

VA San Diego

Recruiting

San Diego, California, United States, 92161

Contacts

Principal Investigator:

Nancy Gardetto, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94117

Contacts

Principal Investigator:

Liviu Klein, MD

Kaiser Permanente San Francisco

Recruiting

San Francisco, California, United States, 94118

Contacts

Principal Investigator:

Jana Svetlichanaya, MD

Nature Coast Clinical Research

Recruiting

Crystal River, Florida, United States, 34429

Contacts

Principal Investigator:

Susan Pasupuleti, MD

Jacksonville Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Principal Investigator:

Michael Koren, MD

Amavita Clinical Research

Recruiting

Miami, Florida, United States, 33137

Contacts

Principal Investigator:

Pedro Martinez Clark, MD

Advance Medical Research Services Corp (AMRS)

Recruiting

Miami, Florida, United States, 33173

Contacts

Principal Investigator:

Yordan Orive Gomez, MD

Baptist Health (Miami Cardiac & Vascular Institute)

Recruiting

Miami, Florida, United States, 33173

Contacts

Principal Investigator:

Sandra Chaparro, MD

Comprehensive Medical & Research Center

Recruiting

Plantation, Florida, United States, 33317

Contacts

Wilmer Santiesteban Garcia, SC

(954) 368-3529wsantiesteban@compmedical.net

Principal Investigator:

William Korey, MD

St. Johns Center for Clinical Research

Recruiting

St. Augustine, Florida, United States, 32086

Contacts

Principal Investigator:

Ameeth Vedre, MD

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Principal Investigator:

Debbie Hoffman, MD

West Georgia Cardiology

Recruiting

Carrollton, Georgia, United States, 30117

Contacts

Principal Investigator:

Charlie Rouse, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Gene Kim, MD

Advocate Illinois Masonic Medical Center

Recruiting

Chicago, Illinois, United States, 60657

Contacts

Principal Investigator:

Sorin Danciu, MD

Advocate Illinois Masonic Health Center

Recruiting

Downers Grove, Illinois, United States, 60515

Contacts

Principal Investigator:

Sorin Danciu, MD

Midwest Cardiovascular Center

Recruiting

Naperville, Illinois, United States, 60540

Contacts

Principal Investigator:

Maria Rosa Costanzo, MD

Robert J. Dole VA Medical Center

Recruiting

Wichita, Kansas, United States, 67218

Contacts

Principal Investigator:

Freidy Eid, MD

St. Elizabeth Healthcare

Recruiting

Edgewood, Kentucky, United States, 41017

Contacts

Principal Investigator:

Haree Vongooru, MD

Cardiovascular Institute of the South

Recruiting

Houma, Louisiana, United States, 70360

Contacts

Principal Investigator:

Peter Fail, MD

Cardiovascular Institute of the South

Recruiting

Lafayette, Louisiana, United States, 70503

Contacts

Principal Investigator:

Wade May, MD

University Medical Center New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Principal Investigator:

Frank Smart, MD

Nebraska Heart Center

Recruiting

Lincoln, Nebraska, United States, 68526

Contacts

Principal Investigator:

Steven Krueger, MD

VA Southern Nevada Healthcare System

Recruiting

North Las Vegas, Nevada, United States, 89086

Contacts

Principal Investigator:

Marriyam Moten, MD

Mount Sinai Morningside

Recruiting

New York, New York, United States, 10025

Contacts

Principal Investigator:

Kiran Mahmood, MD

The Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Anuradha Lala - Trindade, MD

St. Francis Hospital

Recruiting

Roslyn, New York, United States, 11576

Contacts

Principal Investigator:

Rita Jermyn, MD

Mission Hospital

Recruiting

Asheville, North Carolina, United States, 28803

Contacts

Principal Investigator:

Vinay Thohan, MD

Moses H. Cone Memorial Hospital

Recruiting

Greensboro, North Carolina, United States, 27401

Contacts

Principal Investigator:

Daniel Bensimhon, MD

The Lindner Research Center at The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Principal Investigator:

Eugene Chung, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

W.H. Wilson Tang, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Rami Kahwash, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Principal Investigator:

JoAnn Lindenfeld, MD

Rio Grande Regional Hospital

Recruiting

McAllen, Texas, United States, 78503

Contacts

Principal Investigator:

Norman Ramirez, MD

Methodist Hospital of San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Sachin Gupta, MD

More Information

Sponsor

Cordio Medical

Last update posted

Mar 26, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cordio Medical on 2025-03-26.