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BMAD-TX: Benefits of Microcor in Ambulatory Decompensated Heart Failure

Sponsor
Zoll Medical Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04096040
Collaborator
(none)
266
Enrollment
83
Locations
1
Arm
43.9
Anticipated Duration (Months)
3.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: μCor
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
266 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Benefits of Microcor in Ambulatory Decompensated Heart Failure
Actual Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Investigator Engagement of Device Data [Through study completion, an average of 2.5 years.]

    Quantification of investigator actions after viewing device data.

Secondary Outcome Measures

  1. Correlations of the μCor measured thoracic fluid index to heart failure related clinical events. [90 days.]

    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.

  2. Correlations of cardiac rhythm μCor measurements to heart failure related clinical events. [90 days]

    Reading: cardiac rhythm measured as heart rate (beats per minute)Clinical heart failure events will be collected in the Case Report Forms.

  3. Correlations of respiration rate μCor measurements to heart failure related clinical events. [90 days]

    Reading: respiration rateClinical heart failure events will be collected in the Case Report Forms.

  4. Correlations of the μCor measured thoracic fluid index and heart failure related symptoms. [90 days]

    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.

  5. Correlations of cardiac rhythm μCor measurements and heart failure related symptoms. [90 days.]

    Reading: cardiac rhythm measured as heart rate (beats per minute)Heart Failure symptoms assessed through subject reported symptoms captured in the Case Report Forms.

  6. Correlations of respiration rate μCor measurements and heart failure related symptoms. [90 days]

    Reading: respiration rate. Heart Failure symptoms assessed through subject reported symptoms captured in the Case Report Forms.

  7. Incident Rate; Hospital Readmission [90 days, 6 months, 1 year]

    Rate of hospital readmission captured in the Case Report Forms.

  8. Incident Rate; Physician Visit [90 days, 6 months, 1 year]

    Rate of physician visits captured in the Case Report Forms.

  9. Incident Rate; Outpatient Clinic Visit [90 days, 6 months, 1 year]

    Rate of outpatient clinic visits captured in the Case Report Forms.

  10. Mortality; Rate [90 days, 6 months, 1 year]

    Mortality Rate; number of subject deaths captured in the Case Report Forms

  11. Mortality; Cause of Death [90 days, 6 months, 1 year]

    Cause of Death; clinical history captured in the Case Report Forms

  12. Quality of Life by Patient Security Questionnaire [90 days, 6 months, 1 year]

    Quality of Life; measured through and Patient Health Security Questionnaire.

  13. Quality of Life by Kansas City Heart Questionnaire [90 days, 6 months, 1 year]

    Quality of Life; measured through Kansas City Heart Failure Questionnaire.

  14. Health Care Utilization by Cost Estimate [90 days, 6 months, 1 year]

    Health Care Utilization; measured through cost estimates of prescription medications.

  15. Health Care Utilization by Frequency of Prescription Medication Use. [90 days, 6 months, 1 year]

    Health Care Utilization; measured through frequency of prescription medication use reported on the Case Report Forms.

  16. Health Care Utilization by Frequency of Hospital Visits. [90 days, 6 months, 1 year]

    Health Care Utilization; measured through frequency of hospital visits reported on the Case Report Forms.

  17. Health Care Utilization by Frequency of ER visits. [90 days, 6 months, 1 year]

    Health Care Utilization; measured through frequency of emergency room visits reported on the Case Report Forms.

  18. Health Care Utilization by Frequency of physician visits. [90 days, 6 months, 1 year]

    Health Care Utilization; measured through frequency of physician visits reported on the Case Report Forms.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Zoll Medical Corporation

Investigators

  • Study Director: Mike Osz, Zoll Medical Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zoll Medical Corporation
ClinicalTrials.gov Identifier:
NCT04096040
Other Study ID Numbers:
  • 90D0202
First Posted:
Sep 19, 2019
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Jul 11, 2022