RECRUITING

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

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Conditions

Heart Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-11
Study Completion:2024-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06378632

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 22 or greater
  2. 2. Diagnosed with Symptomatic Chronic Heart Failure \[NYHA II-IVa (ambulatory)\]
  3. 3. At least one of the following:
  4. 1. One ADHF hospitalization in the last 12 months
  5. 2. One unplanned IV/SC diuretic administration in the last 6 months
  6. 3. Two unplanned IV/SC diuretic administrations in the last 12 months
  7. 4. NTProBNP \>500 pg/ml
  8. 4. Clinically stable HF according to investigator discretion
  9. 5. Willing to participate as evidenced by signing the written informed consent.
  1. 1. Unable to comply with daily use of the App,
  2. 2. Has had a major cardiovascular event within 3 months prior to enrolment.
  3. 3. Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
  4. 4. Has estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73.
  5. 5. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
  6. 6. Was treated for a significant COPD

Contacts and Locations

Study Contact

Bill Tobin
CONTACT
(203) 852-8900
billt@ihcresearch.com

Principal Investigator

Ronit Haviv, PhD
STUDY_DIRECTOR
Cordio Medical

Study Locations (Sites)

Eastern Shore Research Institute
Fairhope, Alabama, 36532
United States
UC San Diego Health
La Jolla, California, 92037
United States
VA Loma Linda Healthcare System
Loma Linda, California, 92357
United States
VA San Diego
San Diego, California, 92161
United States
University of California, San Francisco
San Francisco, California, 94117
United States
Kaiser Permanente San Francisco
San Francisco, California, 94118
United States
Nature Coast Clinical Research
Crystal River, Florida, 34429
United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
United States
Amavita Clinical Research
Miami, Florida, 33137
United States
Advance Medical Research Services Corp (AMRS)
Miami, Florida, 33173
United States
Baptist Health (Miami Cardiac & Vascular Institute)
Miami, Florida, 33173
United States
Comprehensive Medical & Research Center
Plantation, Florida, 33317
United States
St. Johns Center for Clinical Research
Saint Augustine, Florida, 32086
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
West Georgia Cardiology
Carrollton, Georgia, 30117
United States
University of Chicago
Chicago, Illinois, 60637
United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
United States
Advocate Illinois Masonic Health Center
Downers Grove, Illinois, 60515
United States
Midwest Cardiovascular Center
Naperville, Illinois, 60540
United States
Robert J. Dole VA Medical Center
Wichita, Kansas, 67218
United States
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360
United States
Cardiovascular Institute of the South
Lafayette, Louisiana, 70503
United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States
Nebraska Heart Center
Lincoln, Nebraska, 68526
United States
VA Southern Nevada Healthcare System
North Las Vegas, Nevada, 89086
United States
Mount Sinai Morningside
New York, New York, 10025
United States
The Mount Sinai Hospital
New York, New York, 10029
United States
St. Francis Hospital
Roslyn, New York, 11576
United States
Mission Hospital
Asheville, North Carolina, 28803
United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401
United States
The Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, 45219
United States
Cleveland Clinic
Cleveland, Ohio, 44106
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Rio Grande Regional Hospital
McAllen, Texas, 78503
United States
Methodist Hospital of San Antonio
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Cordio Medical

  • Ronit Haviv, PhD, STUDY_DIRECTOR, Cordio Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-11
Study Completion Date2024-12-01

Study Record Updates

Study Start Date2022-02-11
Study Completion Date2024-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure