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Trial record 1 of 1 for:    BMAD-TX
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Benefits of Microcor in Ambulatory Decompensated Heart Failure (BMAD-TX)

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ClinicalTrials.gov Identifier: NCT04096040
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Zoll Medical Corporation

Tracking Information
First Submitted Date  ICMJE September 12, 2019
First Posted Date  ICMJE September 19, 2019
Last Update Posted Date March 4, 2021
Actual Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
Investigator Engagement of Device Data [ Time Frame: Through study completion, an average of 2.5 years. ]
Quantification of investigator actions after viewing device data.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
  • Correlations of the μCor measured thoracic fluid index to heart failure related clinical events. [ Time Frame: 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.
  • Correlations of cardiac rhythm μCor measurements to heart failure related clinical events. [ Time Frame: 90 days ]
    Reading: cardiac rhythm measured as heart rate (beats per minute)Clinical heart failure events will be collected in the Case Report Forms.
  • Correlations of respiration rate μCor measurements to heart failure related clinical events. [ Time Frame: 90 days ]
    Reading: respiration rateClinical heart failure events will be collected in the Case Report Forms.
  • Correlations of the μCor measured thoracic fluid index and heart failure related symptoms. [ Time Frame: 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.
  • Correlations of cardiac rhythm μCor measurements and heart failure related symptoms. [ Time Frame: 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.
  • Correlations of respiration rate μCor measurements and heart failure related symptoms. [ Time Frame: 90 days ]
    Reading: respiration rate. Heart Failure symptoms assessed through subject reported symptoms captured in the Case Report Forms.
  • Incident Rate; Hospital Readmission [ Time Frame: 90 days, 6 months, 1 year ]
    Rate of hospital readmission captured in the Case Report Forms.
  • Incident Rate; Physician Visit [ Time Frame: 90 days, 6 months, 1 year ]
    Rate of physician visits captured in the Case Report Forms.
  • Incident Rate; Outpatient Clinic Visit [ Time Frame: 90 days, 6 months, 1 year ]
    Rate of outpatient clinic visits captured in the Case Report Forms.
  • Mortality; Rate [ Time Frame: 90 days, 6 months, 1 year ]
    Mortality Rate; number of subject deaths captured in the Case Report Forms
  • Mortality; Cause of Death [ Time Frame: 90 days, 6 months, 1 year ]
    Cause of Death; clinical history captured in the Case Report Forms
  • Quality of Life by Patient Security Questionnaire [ Time Frame: 90 days, 6 months, 1 year ]
    Quality of Life; measured through and Patient Health Security Questionnaire.
  • Quality of Life by Kansas City Heart Questionnaire [ Time Frame: 90 days, 6 months, 1 year ]
    Quality of Life; measured through Kansas City Heart Failure Questionnaire.
  • Health Care Utilization by Cost Estimate [ Time Frame: 90 days, 6 months, 1 year ]
    Health Care Utilization; measured through cost estimates of prescription medications.
  • Health Care Utilization by Frequency of Prescription Medication Use. [ Time Frame: 90 days, 6 months, 1 year ]
    Health Care Utilization; measured through frequency of prescription medication use reported on the Case Report Forms.
  • Health Care Utilization by Frequency of Hospital Visits. [ Time Frame: 90 days, 6 months, 1 year ]
    Health Care Utilization; measured through frequency of hospital visits reported on the Case Report Forms.
  • Health Care Utilization by Frequency of ER visits. [ Time Frame: 90 days, 6 months, 1 year ]
    Health Care Utilization; measured through frequency of emergency room visits reported on the Case Report Forms.
  • Health Care Utilization by Frequency of physician visits. [ Time Frame: 90 days, 6 months, 1 year ]
    Health Care Utilization; measured through frequency of physician visits reported on the Case Report Forms.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Benefits of Microcor in Ambulatory Decompensated Heart Failure
Official Title  ICMJE Benefits of Microcor in Ambulatory Decompensated Heart Failure
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Heart Failure
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Device Data Engagement Assessment
This arm will assess the endpoints of investigator engagement with the device data.
Intervention: Device: μCor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 17, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mike Osz 412-968-3472 mosz@zoll.com
Contact: Tara Roberts 412-968-3333 ext 14559 tara.roberts@zoll.com
Listed Location Countries  ICMJE France,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04096040
Other Study ID Numbers  ICMJE 90D0202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zoll Medical Corporation
Study Sponsor  ICMJE Zoll Medical Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mike Osz Zoll Medical Corporation
PRS Account Zoll Medical Corporation
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP