Benefits of Microcor in Ambulatory Decompensated Heart Failure (BMAD-TX)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: μCor

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Data Engagement Assessment; This arm will assess the endpoints of investigator engagement with the device data.	Device: μCor; μCor consists of the following components: A) Patch B) Sensor C) Charger D) Data transmission device (Gateway) E) Server Once activated, the wearable Sensor automatically acquires ECG, RF readings, heart rate, respiration rate, activity, and posture measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Engagement of Device Data	Quantification of investigator actions after viewing device data.	Through study completion, an average of 2.5 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlations of the μCor measured thoracic fluid index to heart failure related clinical events.	Reading: thoracic impedance index (relative value that is normalized to a baseline radar impedance). Clinical heart failure events will be collected in the Case Report Forms.	90 days.
Correlations of cardiac rhythm μCor measurements to heart failure related clinical events.	Reading: cardiac rhythm measured as heart rate (beats per minute)Clinical heart failure events will be collected in the Case Report Forms.	90 days
Correlations of respiration rate μCor measurements to heart failure related clinical events.	Reading: respiration rateClinical heart failure events will be collected in the Case Report Forms.	90 days
Correlations of the μCor measured thoracic fluid index and heart failure related symptoms.	Reading: thoracic impedance index (relative value that is normalized to a baseline radar impedance).Heart Failure symptoms assessed through subject reported symptoms captured in the Case Report Forms.	90 days
Correlations of cardiac rhythm μCor measurements and heart failure related symptoms.	Reading: cardiac rhythm measured as heart rate (beats per minute)Heart Failure symptoms assessed through subject reported symptoms captured in the Case Report Forms.	90 days.
Correlations of respiration rate μCor measurements and heart failure related symptoms.	Reading: respiration rate. Heart Failure symptoms assessed through subject reported symptoms captured in the Case Report Forms.	90 days
Incident Rate; Hospital Readmission	Rate of hospital readmission captured in the Case Report Forms.	90 days, 6 months, 1 year
Incident Rate; Physician Visit	Rate of physician visits captured in the Case Report Forms.	90 days, 6 months, 1 year
Incident Rate; Outpatient Clinic Visit	Rate of outpatient clinic visits captured in the Case Report Forms.	90 days, 6 months, 1 year
Mortality; Rate	Mortality Rate; number of subject deaths captured in the Case Report Forms	90 days, 6 months, 1 year
Mortality; Cause of Death	Cause of Death; clinical history captured in the Case Report Forms	90 days, 6 months, 1 year
Quality of Life by Patient Security Questionnaire	Quality of Life; measured through and Patient Health Security Questionnaire.	90 days, 6 months, 1 year
Quality of Life by Kansas City Heart Questionnaire	Quality of Life; measured through Kansas City Heart Failure Questionnaire.	90 days, 6 months, 1 year
Health Care Utilization by Cost Estimate	Health Care Utilization; measured through cost estimates of prescription medications.	90 days, 6 months, 1 year
Health Care Utilization by Frequency of Prescription Medication Use.	Health Care Utilization; measured through frequency of prescription medication use reported on the Case Report Forms.	90 days, 6 months, 1 year
Health Care Utilization by Frequency of Hospital Visits.	Health Care Utilization; measured through frequency of hospital visits reported on the Case Report Forms.	90 days, 6 months, 1 year
Health Care Utilization by Frequency of ER visits.	Health Care Utilization; measured through frequency of emergency room visits reported on the Case Report Forms.	90 days, 6 months, 1 year
Health Care Utilization by Frequency of physician visits.	Health Care Utilization; measured through frequency of physician visits reported on the Case Report Forms.	90 days, 6 months, 1 year

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Investigators: Study Director: Mike Osz, Zoll Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 90D0202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes