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NCT03476187Completed

Benefits of µCor in Ambulatory Decompensated Heart Failure

Source: ClinicalTrials.gov · Last updated 8 Jan 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
257 (actual)
First submitted
19 Feb 2018
Start date
17 Aug 2018
Primary completion date
8 Jan 2024
Lead sponsor
Zoll Medical Corporation
NCT number
NCT03476187

What you commit to

  • Study type: Interventional
  • Participants enrolled: 257
  • From 17 Aug 2018 to the primary completion date, 8 Jan 2024
  • 61 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Subjects not expected to survive one year from enrollment from non-cardiac disease.
  • Subjects with skin allergy or sensitivity to medical adhesives.
  • Subjects whose primary diagnosis on hospital admission was Acute Coronary Syndrome (ACS) STEMI/NSTEMI rather than heart failure exacerbation.

Other

  • Subjects who are wearing the wearable cardioverter defibrillator (WCD)
  • Subjects anticipated to start dialysis within 90 days.
  • Subjects currently implanted with an S-ICD system.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (61)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitätsklinik für Innere Medizin II, Abteilung für Kardiologie
Coordinator of this site? Confirm its status
ViennaAustriaUnknown status
St. Vinzenz-Hospital; Akademisches Lehrkrankenhaus der Universität zu Köln, Innere Medizin III
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CologneGermanyUnknown status
Herzzentrum Leipzig GmbH
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LeipzigGermanyUnknown status
Klinikum rechts der Isar - Technische Universität München, Klinik und Poliklinik für Innere Medizin I
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MunichGermanyUnknown status
PharmaTex Research
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AmarilloUnited StatesUnknown status
Fox Valley Clinical Research Center
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AuroraUnited StatesUnknown status
Grace Research LLC
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Bossier CityUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Nova Clinical Research, LLC
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BradentonUnited StatesUnknown status
Trinity Medical WNY
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BuffaloUnited StatesUnknown status
The Loretto Hospital
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ChicagoUnited StatesUnknown status
Palmetto Health Advanced Heart Health Center
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ColumbiaUnited StatesUnknown status
South Palm Cardiovascular Research Institute
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Delray BeachUnited StatesUnknown status
UMPC Hamot
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ErieUnited StatesUnknown status
Cardiology Institute of Michigan
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FlintUnited StatesUnknown status
Holy Cross Medical Group
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Fort LauderdaleUnited StatesUnknown status
JPS Health Network
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Fort WorthUnited StatesUnknown status
Texas Cardiovascular Institute
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Fort WorthUnited StatesUnknown status
The Cardiac and Vascular Institute Research Foundation
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GainesvilleUnited StatesUnknown status
Nebraska Heart Institute
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Grand IslandUnited StatesUnknown status
East Carolina Heart Institute
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GreenvilleUnited StatesUnknown status
Chicago Medical Research LLC
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Hazel CrestUnited StatesUnknown status
Northwest Houston Cardiology
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HoustonUnited StatesUnknown status
Marshall Cardiology
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HuntingtonUnited StatesUnknown status
The Jackson Clinic, PA
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JacksonUnited StatesUnknown status
Baptist Heart Specialists
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JacksonvilleUnited StatesUnknown status
NEA Baptist Clinic
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JonesboroUnited StatesUnknown status
Lancaster General Hospital
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LancasterUnited StatesUnknown status
The Heart Institute at Largo
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LargoUnited StatesUnknown status
University Medical Center of Southern Nevada
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Las VegasUnited StatesUnknown status
Nebraska Heart Institute
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LincolnUnited StatesUnknown status
New Jersey Heart
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LindenUnited StatesUnknown status
SJH Cardiology Associates
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LiverpoolUnited StatesUnknown status
Cardiovascular Innovation and Research Center, Inc.
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Long BeachUnited StatesUnknown status
Los Alamitos Cardiovascular
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Los AlamitosUnited StatesUnknown status
Loyola University Medical Center
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MaywoodUnited StatesUnknown status
Texas Institute of Cardiology
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McKinneyUnited StatesUnknown status
CardioVogage
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McKinneyUnited StatesUnknown status
Mount Sinai Medical Center
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Miami BeachUnited StatesUnknown status
Hennepen Healthcare Research Institute
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MinneapolisUnited StatesUnknown status
Mobile Heart Specialists PC
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MobileUnited StatesUnknown status
University Hospital
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MobileUnited StatesUnknown status
Clinical Trials of America, LLC
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MonroeUnited StatesUnknown status
Riverside Hospital Inc.
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Newport NewsUnited StatesUnknown status
Cardiovascular Institute of Central Florida
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OcalaUnited StatesUnknown status
OUHSC
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Oklahoma CityUnited StatesUnknown status
Unity Point Health Cardiovascular Services
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PeoriaUnited StatesUnknown status
AtlantiCare Regional Medical Center
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PomonaUnited StatesUnknown status
NC Heart & Vascular Research
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RaleighUnited StatesUnknown status
Henrico Doctors' Hospital
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RichmondUnited StatesUnknown status
Chippenham Hospital
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RichmondUnited StatesUnknown status
University of Rochester Medical Center
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RochesterUnited StatesUnknown status
The Guthrie Clinic
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SayreUnited StatesUnknown status
Northside hospital
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St. PetersburgUnited StatesUnknown status
University of South Florida Dept of Cardiovascular Sciences
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TampaUnited StatesUnknown status
Cardiology Practice Tampa
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TampaUnited StatesUnknown status
Cardiovascular Consultants of South Georgia
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ThomasvilleUnited StatesUnknown status
Clinical Trials of America, LLC
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West MonroeUnited StatesUnknown status
DuPage Medical Group
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WinfieldUnited StatesUnknown status
Wake Forest University Health Sciences
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Winston-SalemUnited StatesUnknown status
Cardiology Consultants of Philadelphia
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YardleyUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.