Heart Failure Clinical Trial

Benefits of Microcor in Ambulatory Decompensated Heart Failure

Summary

To assess investigator engagement of μCor system data in the context of heart failure management. The μCor system includes a sensor and wearable patch for fluid management.

View Full Description

Full Description

Subjects meeting the inclusion/exclusion criteria will wear the μCor for up to 90 days.

During the study, face to face follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac signs, symptoms, and any relevant clinically actionable events.

The subject will be given a daily diary to track symptoms, 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.

The subject's health care provider team will receive the μCor data through access to a clinical tool interface. The clinical tool will send data updates that are dependent on the μCor data trends. The data updates will allow the health care provider team to take action when the data indicate worsening heart failure, within the context of standard of care medical practice and patient specific parameters. Weekly data reports will be delivered to the investigators.

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

4.1.1 Subjects hospitalized for acute decompensated heart failure and enrolled in the study within 10 days post-hospital discharge.
4.1.2 Subjects who have had an acute heart failure event requiring medical management in the previous 180 days of index hospitalization admission. This acute heart failure event admission must be at least 2 weeks apart from the event admission in 4.1.1
4.1.3 Subjects 21 years of age or older on the day of screening.

Exclusion Criteria:

4.2.1 Subjects who are wearing the wearable cardioverter defibrillator (WCD)
4.2.2 Subjects not expected to survive one year from enrollment from non-cardiac disease.
4.2.3 Subjects with skin allergy or sensitivity to medical adhesives.
4.2.4 Subjects anticipated to start dialysis within 90 days.
4.2.5 Subjects currently implanted with an S-ICD system.
4.2.6 Subjects who received a percutaneous coronary intervention (PCI) less than 24 hours after onset of heart failure related symptoms during index hospitalization.
4.2.7 Subjects who are unable to participate in all follow up visits.
4.2.8 Subjects participating in research other than a registry at the time of enrollment.
4.2.9 Subjects currently implanted with an LVAD.
4.2.10 Subjects with self-reported pregnancy.
4.2.11 Subjects currently being actively managed with any device based remote HF monitoring.

Study is for people with:

Heart Failure

Estimated Enrollment:

266

Study ID:

NCT04096040

Recruitment Status:

Completed

Sponsor:

Zoll Medical Corporation

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There are 74 Locations for this study

See Locations Near You

SYED Research Consultants LLC
Sheffield Alabama, 35660, United States
TriWest Research
El Cajon California, 92020, United States
Zillan Clinical Research
Inglewood California, 90301, United States
Axis Clinical Trials
Los Angeles California, 90036, United States
InvivoCure LLC
Mission Hills California, 91345, United States
ACRC Studies
San Diego California, 92119, United States
Aventura Clinical Research LLC
Aventura Florida, 33180, United States
Accel Research Sites - Guardian
Davenport Florida, 33837, United States
Accel Research Sites- Daytona Heart Group
DeLand Florida, 32720, United States
Accel Research Sites - Guardian Winter Park
Deltona Florida, 32725, United States
Holy Cross Hospital, Medical Group, Cardiology Associates
Fort Lauderdale Florida, 33308, United States
Elite Cardiac Research Center
Hialeah Florida, 33013, United States
Inpatient Research Clinic
Hialeah Florida, 33013, United States
Homestead Associates in Research
Miami Florida, 32032, United States
Westchester Research Center at Westchester General Hospital
Miami Florida, 33155, United States
Miramax Clinical Research Inc
North Miami Florida, 33169, United States
Ocala Cardiovascular Research
Ocala Florida, 34471, United States
Accel Research Sites
Orlando Florida, 32837, United States
DBC Research
Tamarac Florida, 33321, United States
Winter Haven Hospital - BayCare Health System
Winter Haven Florida, 33880, United States
Accel Research Sites - Guardian Winter Park
Winter Park Florida, 32792, United States
Emory University School of Medicine
Atlanta Georgia, 30303, United States
Columbus Cardiology Associates
Columbus Georgia, 31904, United States
Accel Research Sites - Lake County Medical Group
Eatonton Georgia, 31024, United States
Quincy Medical Group
Quincy Illinois, 62301, United States
Cardiovascular Research of Northwest Indiana, LLC
Munster Indiana, 46321, United States
Reid Physician Associates
Richmond Indiana, 47374, United States
Beacon Medical Group
South Bend Indiana, 46601, United States
Norton Heart Specialists
Louisville Kentucky, 40205, United States
Research Integrity, LLC
Owensboro Kentucky, 42303, United States
Heart Clinic of Hammond
Hammond Louisiana, 70403, United States
Sinai Center for Thrombosis Reserach and Drug Development
Baltimore Maryland, 21784, United States
Intervent Clinical Research Center
Pembroke Hills Maryland, 33024, United States
Peninsula Regional Medical Center
Salisbury Maryland, 21804, United States
Ascension Providence Rochester Hospital
Rochester Michigan, 48307, United States
Ascension St. Mary's Research Institute
Saginaw Michigan, 48601, United States
Jackson Heart Clinic
Jackson Mississippi, 48601, United States
Kansas City Cardiology
Lee's Summit Missouri, 64064, United States
Gateway Cardiovascular Research Center, Inc
Saint Louis Missouri, 63128, United States
St. Louis Heart and Vascular
Saint Louis Missouri, 63136, United States
Bryan Heart
Lincoln Nebraska, 68506, United States
Methodist Physicians Clinical Heart Consultants
Omaha Nebraska, 68114, United States
Virtua Health
Cherry Hill New Jersey, 08034, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Jersey Shore University Medical Center
Neptune New Jersey, 07753, United States
BronxCare Health System at BronxCare Hospital Center
Bronx New York, 10457, United States
Bassett Medical Center
Cooperstown New York, 13326, United States
Laurelton Heart Specialist
Rosedale New York, 11422, United States
Macklenberg Heart Specialists / Focus Clinical Research Solutions
Charlotte North Carolina, 28207, United States
Heart House Research Foundation
Springfield Ohio, 45504, United States
Mercy Health St. Vincent Medical Center
Toledo Ohio, 43608, United States
INTEGRIS Baptist Medical Center
Oklahoma City Oklahoma, 73112, United States
Penn State Health Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Mercer Bucks Cardiology at Jefferson Health
Newtown Pennsylvania, 18940, United States
Cardiovascular Institute
Pittsburgh Pennsylvania, 15212, United States
Frontier Clinical Research, LLC
Smithfield Pennsylvania, 15478, United States
Carolina Heart Specialists
Lancaster South Carolina, 77598, United States
Knoxville HMA Cardiology, PPM, LLC
Knoxville Tennessee, 37934, United States
North Texas Research Associates
Allen Texas, 75013, United States
North Houston Cardiology Center
Cypress Texas, 77429, United States
JPS Health Network
Fort Worth Texas, 76104, United States
North Texas Research Associates
McKinney Texas, 75071, United States
Texas Institute of Cardiology
McKinney Texas, 75071, United States
Mission Research Institue
New Braunfels Texas, 78130, United States
Bay Area Heart
Webster Texas, 77598, United States
Stroobants Cardiovascular Center
Lynchburg Virginia, 24501, United States
Pulse Heart Institute
Puyallup Washington, 98372, United States
Klinikum Klagenfurt am Wörthersee
Klagenfurt , 9020, Austria
Klinik Favoriten
Wien , 1100, Austria
Centre Hospitalier Régional Universitaire de Lille - Hôpital Cardiologique
Lille , 59037, France
CHU Montpellier - Hopital Arnaud de Villeneuve
Montpellier , 34295, France
Chu Montpellier - Hopital Arnaud de Villeneuve
Montpellier , , France
Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5
Paris , 75015, France
Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5
Paris , , France
Albertinen Krankenhaus HH
Hamburg GG, 22457, Germany
Kerckhoff-Klinik GmbH
Bad Nauheim , 06032, Germany
Kerckhoff-Klinik GmbH
Bad Nauheim , , Germany
Universitätsklinikum Frankfurt
Frankfort , 60590, Germany
Universitätsklinikum Gießen und Marburg GmbH
Gießen , 35392, Germany
Albertinen Krankenhaus Hamburg
Hamburg , , Germany
Medizinische Hochschule Hannover
Hannover , 30625, Germany
Medizinische Hochschule Hannover
Hannover , , Germany
Herzzentrum Leipzig, Universitätsklinik für Kardiologie Abteilung Rhythmologie
Leipzig , 4289, Germany

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

266

Study ID:

NCT04096040

Recruitment Status:

Completed

Sponsor:


Zoll Medical Corporation

How clear is this clinincal trial information?

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