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
- Diseases
- Heart failure
- 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
Sites (61)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinik für Innere Medizin II, Abteilung für Kardiologie Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| St. Vinzenz-Hospital; Akademisches Lehrkrankenhaus der Universität zu Köln, Innere Medizin III Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Herzzentrum Leipzig GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Klinikum rechts der Isar - Technische Universität München, Klinik und Poliklinik für Innere Medizin I Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| PharmaTex Research Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| Fox Valley Clinical Research Center Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Grace Research LLC Coordinator of this site? Confirm its status | Bossier City | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Nova Clinical Research, LLC Coordinator of this site? Confirm its status | Bradenton | United States | Unknown status |
| Trinity Medical WNY Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| The Loretto Hospital Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Palmetto Health Advanced Heart Health Center Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| South Palm Cardiovascular Research Institute Coordinator of this site? Confirm its status | Delray Beach | United States | Unknown status |
| UMPC Hamot Coordinator of this site? Confirm its status | Erie | United States | Unknown status |
| Cardiology Institute of Michigan Coordinator of this site? Confirm its status | Flint | United States | Unknown status |
| Holy Cross Medical Group Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| JPS Health Network Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Texas Cardiovascular Institute Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| The Cardiac and Vascular Institute Research Foundation Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Nebraska Heart Institute Coordinator of this site? Confirm its status | Grand Island | United States | Unknown status |
| East Carolina Heart Institute Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Chicago Medical Research LLC Coordinator of this site? Confirm its status | Hazel Crest | United States | Unknown status |
| Northwest Houston Cardiology Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Marshall Cardiology Coordinator of this site? Confirm its status | Huntington | United States | Unknown status |
| The Jackson Clinic, PA Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Baptist Heart Specialists Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| NEA Baptist Clinic Coordinator of this site? Confirm its status | Jonesboro | United States | Unknown status |
| Lancaster General Hospital Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| The Heart Institute at Largo Coordinator of this site? Confirm its status | Largo | United States | Unknown status |
| University Medical Center of Southern Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Nebraska Heart Institute Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| New Jersey Heart Coordinator of this site? Confirm its status | Linden | United States | Unknown status |
| SJH Cardiology Associates Coordinator of this site? Confirm its status | Liverpool | United States | Unknown status |
| Cardiovascular Innovation and Research Center, Inc. Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Los Alamitos Cardiovascular Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
| Loyola University Medical Center Coordinator of this site? Confirm its status | Maywood | United States | Unknown status |
| Texas Institute of Cardiology Coordinator of this site? Confirm its status | McKinney | United States | Unknown status |
| CardioVogage Coordinator of this site? Confirm its status | McKinney | United States | Unknown status |
| Mount Sinai Medical Center Coordinator of this site? Confirm its status | Miami Beach | United States | Unknown status |
| Hennepen Healthcare Research Institute Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Mobile Heart Specialists PC Coordinator of this site? Confirm its status | Mobile | United States | Unknown status |
| University Hospital Coordinator of this site? Confirm its status | Mobile | United States | Unknown status |
| Clinical Trials of America, LLC Coordinator of this site? Confirm its status | Monroe | United States | Unknown status |
| Riverside Hospital Inc. Coordinator of this site? Confirm its status | Newport News | United States | Unknown status |
| Cardiovascular Institute of Central Florida Coordinator of this site? Confirm its status | Ocala | United States | Unknown status |
| OUHSC Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Unity Point Health Cardiovascular Services Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| AtlantiCare Regional Medical Center Coordinator of this site? Confirm its status | Pomona | United States | Unknown status |
| NC Heart & Vascular Research Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Henrico Doctors' Hospital Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Chippenham Hospital Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| The Guthrie Clinic Coordinator of this site? Confirm its status | Sayre | United States | Unknown status |
| Northside hospital Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| University of South Florida Dept of Cardiovascular Sciences Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Cardiology Practice Tampa Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Cardiovascular Consultants of South Georgia Coordinator of this site? Confirm its status | Thomasville | United States | Unknown status |
| Clinical Trials of America, LLC Coordinator of this site? Confirm its status | West Monroe | United States | Unknown status |
| DuPage Medical Group Coordinator of this site? Confirm its status | Winfield | United States | Unknown status |
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| Cardiology Consultants of Philadelphia Coordinator of this site? Confirm its status | Yardley | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.