Benefits of µCor in Ambulatory Decompensated Heart Failure

NCT03476187 | Completed Results FDA Device

• 1 other identifier: 90D0182
• Study Type: interventional
• Target: 257
• Locations: 3 countries
• Sites: 61

Brief Summary

Subjects meeting the inclusion/exclusion criteria will wear the µCor for at least 90 days. During the study, clinic follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac symptoms and any relevant clinically actionable events. The subject will be given a daily diary to track symptoms, unplanned hospital visits, medication changes, and all other heart failure related clinical events. Weekly phone calls to the subject will be given throughout the duration of the study to remind the patient to use the subject diary and to collect and record heart failure related clinical events. Subjects will be contacted six months and one year from initial enrollment to assess the vital status of the subject, any heart failure related clinical events since the end of µCor wear, and any health care utilization since the end of µCor wear.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Correlation of μCor Readings to Heart Failure Related Clinical Events

  HF Event: a hospitalization primarily due to heart failure within 90 days. Time window: The 7 days prior to the 1st heart failure hospitalization, or the final 7 days of device wear if no HF event occurred.

  3 months

• Correlation of µCor Readings to Heart Failure Related Clinical Events

  Definitions: Daytime: 7:00 AM - 12:00 AM Nighttime: 12:00 AM - 7:00 AM For each day on which the subject wore the device, the following values were calculated: Daytime activity: The proportion of minutes while wearing the device that the subject spent active (unitless). Nighttime heart rate: The median heart rate while wearing the device during the night (beats/min) Thoracic fluid index: The median proportion of ratio of radiofrequency-measured lung fluid readings compared to the subject's baseline (unitless). Nighttime posture: The median pitch angle while wearing the device during the night (degrees, where 0 is the horizontal). Nighttime respiration: The median respiration rate while wearing the device during the night (breaths/min) HF event: a hospitalization primarily due to heart failure

  3 months

Secondary Outcomes (10)

• Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects

  Baseline, 90 days, 1 YR

• Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve

  3 months

• Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms

  3 months

• Frequency of Subject Reported Symptoms

  3 months

• Timing of Subject Reported Symptoms

  3 months

Study Arms (1)

µCor wearers

EXPERIMENTAL

Wear the µCor device

Device: µCor

Interventions

µCor DEVICE

Monitor with µCor

µCor wearers

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects either hospitalized for decompensated systolic, diastolic, or combined heart failure or subjects presenting at an outpatient clinic with a history of hospital discharge for decompensated systolic, diastolic, or combined heart failure within the previous 10 days.
• All subjects must be 21 years of age or older on the day of screening.

You may not qualify if:

• Subjects who are wearing the wearable cardioverter defibrillator (WCD)
• Subjects not expected to survive one year from enrollment from non-cardiac disease.
• Subjects with skin allergy or sensitivity to medical adhesives.
• Subjects anticipated to start dialysis within 90 days.
• Subjects currently implanted with an S-ICD system.
• Subjects whose primary diagnosis on hospital admission was Acute Coronary Syndrome (ACS) STEMI/NSTEMI rather than heart failure exacerbation.
• Subjects who are unable to participate in all follow up visits.
• Subjects participating in any other research at time of enrollment.
• Subjects currently implanted with an LVAD.

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (61)

Mobile Heart Specialists, PC

Mobile, Alabama, 36608, United States

Location

University Hospital

Mobile, Alabama, 36617, United States

Location

NEA Baptist Clinic

Jonesboro, Arkansas, 72405, United States

Location

Cardiovascular Innovation and Research Center, Inc.

Long Beach, California, 90813, United States

Location

Los Alamitos Cardiovascular

Los Alamitos, California, 90720, United States

Location

Nova Clinical Research LLC

Bradenton, Florida, 34209, United States

Location

South Palm Cardiovascular Research Institute

Delray Beach, Florida, 33446, United States

Location

Holy Cross Medical Group

Fort Lauderdale, Florida, 33308, United States

Location

The Cardiac and Vascular Institute Research Foundation

Gainesville, Florida, 32605, United States

Location

Baptist Heart Specialists

Jacksonville, Florida, 32250, United States

Location

The Heart Institute at Largo

Largo, Florida, 33770, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Cardiovascular Institute of Central Florida

Ocala, Florida, 34471, United States

Location

Northside Hospital

St. Petersburg, Florida, 33709, United States

Location

University of South Florida Dept of Cardiovascular Sciences

Tampa, Florida, 33609, United States

Location

Cardiology Practice Tampa

Tampa, Florida, 33613, United States

Location

Cardiovascular Consultants of South Georgia

Thomasville, Georgia, 31792, United States

Location

Fox Valley Clinical Research Center

Aurora, Illinois, 60506, United States

Location

The Loretto Hospital

Chicago, Illinois, 60644, United States

Location

Chicago Medical Research LLC

Hazel Crest, Illinois, 60429, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Unity Point Health Cardiovascular Services

Peoria, Illinois, 61606, United States

Location

DuPage Medical Group

Winfield, Illinois, 60190, United States

Location

Grace Research LLC

Bossier City, Louisiana, 71111, United States

Location

Clinical Trials of America, LLC

Monroe, Louisiana, 71201, United States

Location

Clinical Trials of America, LLC

West Monroe, Louisiana, 71291, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Cardiology Institute of Michigan

Flint, Michigan, 48507, United States

Location

Hennepen Healthcare Research Institute

Minneapolis, Minnesota, 55415, United States

Location

Nebraska Heart Institute

Grand Island, Nebraska, 68803, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

New Jersey Heart

Linden, New Jersey, 07036, United States

Location

AtlantiCare Regional Medical Center

Pomona, New Jersey, 08240, United States

Location

Trinity Medical WNY

Buffalo, New York, 14215, United States

Location

SJH Cardiology Associates

Liverpool, New York, 13088, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

East Carolina Heart Institute

Greenville, North Carolina, 27834, United States

Location

NC Heart & Vascular Research

Raleigh, North Carolina, 27607, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

OUHSC

Oklahoma City, Oklahoma, 73104, United States

Location

UMPC Hamot

Erie, Pennsylvania, 16550, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

The Guthrie Clinic

Sayre, Pennsylvania, 18840, United States

Location

Cardiology Consultants of Philadelphia

Yardley, Pennsylvania, 19067, United States

Location

Palmetto Health Advanced Heart Health Center

Columbia, South Carolina, 29203, United States

Location

The Jackson Clinic, PA

Jackson, Tennessee, 38301, United States

Location

PharmaTex Research

Amarillo, Texas, 79106, United States

Location

JPS Health Network

Fort Worth, Texas, 76104, United States

Location

Texas Cardiovascular Institute

Fort Worth, Texas, 76104, United States

Location

Northwest Houston Cardiology

Houston, Texas, 77070, United States

Location

CardioVogage

McKinney, Texas, 75071, United States

Location

Texas Institute of Cardiology

McKinney, Texas, 75071, United States

Location

Riverside Hospital Inc.

Newport News, Virginia, 23601, United States

Location

Chippenham Hospital

Richmond, Virginia, 23225, United States

Location

Henrico Doctors Hospital

Richmond, Virginia, 23229, United States

Location

Marshall Cardiology

Huntington, West Virginia, 25701, United States

Location

Universitätsklinik für Innere Medizin II, Abteilung für Kardiologie

Vienna, Austria

Location

St. Vinzenz-Hospital; Akademisches Lehrkrankenhaus der Universität zu Köln, Innere Medizin III

Cologne, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Klinikum rechts der Isar - Technische Universität München, Klinik und Poliklinik für Innere Medizin I

Munich, Germany

Location

Related Publications (1)

• Boehmer JP, Cremer S, Abo-Auda WS, Stokes DR, Hadi A, McCann PJ, Burch AE, Bonderman D. Impact of a Novel Wearable Sensor on Heart Failure Rehospitalization: An Open-Label Concurrent-Control Clinical Trial. JACC Heart Fail. 2024 Dec;12(12):2011-2022. doi: 10.1016/j.jchf.2024.07.022. Epub 2024 Oct 9.

  PMID: 39387771 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

This study was conducted from 8/17/2018 to 12/1/2022 and partially overlapped with the COVID-19 Pandemic.

Results Point of Contact

• Title: Nicole Bianco
• Organization: ZOLL

NBianco@zoll.com

4129683333

Study Officials

• Steven J. Szymkiewicz, MD

  Zoll Medical Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: March 23, 2018
• Study Start: August 17, 2018
• Primary Completion: January 8, 2024
• Study Completion: April 9, 2024
• Last Updated: January 8, 2025
• Results First Posted: August 28, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); AU (1); US (57)