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    Clinical Outcomes: BMAD Trial

    Peer-reviewed results published in JACC Heart Failure demonstrate the impact of utilizing ZOLL® Heart Failure Management System* (HFMS).

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    Benefits of Microcor (μCor™) in Ambulatory Decompensated Heart Failure (BMAD) Trial

    Purpose

    Evaluate the strategy of using data from a novel radiofrequency sensor to manage heart failure compared to a concurrent control group.

     

    Methods

    This multicenter, multinational, prospective, concurrent control clinical trial compared heart failure hospitalization by time to first event between two study arms – BMAD-HF (control) and BMAD-TX (intervention). The primary endpoint was a comparison of heart failure hospitalization by time to first event between the two study arms.

    BMAD-HF (Control Arm)

    • N=245
    • Followed for >90 days (N=168)
    • All subjects wore the device
    • Weekly structured patient calls
    • Investigators and subjects were blinded to device data

    BMAD-TX (Intervention Arm)

    • N=249
    • Followed for >90 days (N=176)
    • All subjects wore the device
    • Weekly structured patient calls
    • Investigators received the device data for consideration in patient care

    Results

    Use of ZOLL HFMS resulted in a 38% relative risk reduction in HF readmissions at 90 days and a lasting 29% relative risk reduction in readmissions at 1-year.1,2

    BMAD Trial Primary Endpoint: ZOLL Heart Failure Management System (HFMS) shown to reduce 90-day HF readmissions 1-year results of the Benefits of MicroCor in Ambulatory Decompensated Heart Failure (BMAD) trial demonstrate that the use of ZOLL Heart Failure Management System* (HFMS) in clinical practice reduces heart failure readmissions by 29% at one year.
    BMAD Trial Results: Quality of Life Results graph

    Quality of life results

    • Both arms experienced an average improvement in quality of life. 
    • BMAD-TX arm reported an average increase in quality of life that was 12 points higher than patients in the BMAD-HF arm (p=.004).
    • The responder analysis revealed that nearly 70% of patients in the BMAD-TX arm reported a clinically meaningful improvement in quality of life (90 of 137 patients) compared with 50% of patients in the BMAD-HF arm (67 of 133 patients).

    Conclusions

    • This open-label concurrent-control clinical study demonstrates that a strategy of managing HF with the use of a threshold alert from the HFMS system results in a 38% relative risk reduction in HF readmissions after a HF hospitalization. 
    • The percentage of patients who suffered an HF readmission was reduced by an absolute value of 7%, or a number needed to treat of 14.3 patients, to prevent 1 patient from having a HF readmission. 
    • A composite endpoint including survival and HF events such as hospitalization and urgent care visits was included as a supplemental analysis and also demonstrated a 38% relative risk reduction. 
    • Quality of life, as measured by the KCCQ-12, was improved in the intervention arm, and the magnitude of benefit, 12 points greater improvement than in the control arm, was clinically meaningful.
    • The use of HFMS in clinical practice reduces heart failure readmission rates by 29% out to one year.

    *FDA registered name: μCor Heart Failure and Arrhythmia Management System

    1. Boehmer, J, Cremer, S, Abo-Auda, W. et al. Impact of a Novel Wearable Sensor on Heart Failure Rehospitalization: An Open-Label Concurrent-Control Clinical Trial. J Am Coll Cardiol HF. 2024 Dec, 12 (12) 2011–2022. https://doi.org/10.1016/j.jchf.2024.07.022
    2. Boehmer, J. (2025) Reduced heart failure rehospitalization at 1 year for patients wearing a radiofrequency based sensor [Abstract]. In Proceedings of the THT 2025 Conference. Boston, MA. https://www.jacc.org/doi/10.1016/j.jchf.2024.07.022

     

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