Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07776964
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mobile Cardiac Telemetry — DEVICE
    Participants will wear the FDA-cleared BodyGuardian Mini Plus mobile cardiac telemetry patch device for continuous ECG monitoring. The device will collect near-real-time heart rhythm data to identify arrhythmias during and following cancer treatment.
  • Wearable Cardiac Monitor — DEVICE
    Participants will wear an investigational non-significant risk wearable cardiac monitor patch that records heart sounds using an accelerometer. Data from the device will be used for offline analyses and will not be used for clinical decision-making in this study.

Study Details

This pilot study will evaluate the validity and feasibility of ambulatory cardiac monitoring to identify markers of cardiotoxicity in adults undergoing cancer treatment. Participants with breast cancer, hematologic malignancy, or multiple myeloma will receive usual care plus two wearable patch monitors: mobile cardiac telemetry using the BodyGuardian Mini Plus ambulatory ECG monitor and an investigational wearable cardiac monitor that records heart sounds. The study will assess arrhythmias detected by mobile cardiac telemetry and explore whether heart sounds are associated with echocardiographic findings and cardiac biomarkers. Participants will wear the devices during cancer treatment, with monitoring periods at baseline and possible repeat monitoring at 6-month and 12-month study visits.

Key Dates

First listed
Aug 20, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Mar 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
72 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Mobile Cardiac Telemetry and Wearable Cardiac Monitor With Usual Care
    Participants with cancer will receive usual care plus mobile cardiac telemetry using the BodyGuardian Mini Plus ambulatory ECG monitor and a wearable cardiac monitor patch to collect heart sounds. Devices will be worn during cancer treatment to collect arrhythmia and cardiac function monitoring data.

Primary Outcome Measure

Incident Atrial or Ventricular Arrhythmia [ Time Frame: Up to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M Health Fairview Clinics and Surgery CenterMinneapolisMinnesota55455
Samantha Wansing
[email protected]
612-625-4465
Suma Konety, MD (PRINCIPAL_INVESTIGATOR)

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By research site
M Health Fairview Clinics and Surgery Center· Minneapolis, MN

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