ClinicalTrials.gg
Not yet recruitingNCT07776964Updated Nov 2, 2026

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

An interventional study of Mobile Cardiac Telemetry and Wearable Cardiac Monitor in Cardiotoxicity, Cancer and Cardiac Arrhythmia, sponsored by University of Minnesota. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by University of Minnesota · Not applicable, Interventional, and Diagnostic

Updated Nov 2, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Cancer patients may develop cardiovascular complications during cancer treatment, including cardiac arrhythmias, cardiac dysfunction, hypertension, heart failure, and other cardiotoxic effects. Early recognition of cardiotoxicity may help inform monitoring strategies and clinical management during and after cancer treatment.

MCT-WAVE is a prospective, single-arm exploratory pilot study enrolling adults with breast cancer, hematologic malignancy, or multiple myeloma. Each participant will receive usual care plus two wearable patch-based cardiac monitoring devices. Mobile cardiac telemetry will be performed using the FDA-cleared Preventice BodyGuardian Mini Plus ambulatory ECG monitor to collect continuous heart rhythm data. A wearable cardiac monitor patch will also be used to record heart sounds using an accelerometer. Data from the wearable cardiac monitor will be collected for offline analysis and will not be used to guide clinical decision-making in this study.

Participants will be screened for eligibility and, after informed consent, will be fitted with the wearable devices. Baseline data will be collected through electronic medical record review, including demographics, medical history, laboratory values, EKG results, echocardiogram results, medications, cancer treatment information, and clinical events. Participants will receive instructions on how to use and return the devices.

The mobile cardiac telemetry device will be worn for 14 consecutive days and will collect near-real-time ECG data. The wearable cardiac monitor will also be worn for 14 days and will collect heart sounds data. Additional device placement may occur at the 6-month and 12-month study visits. Participants will continue to receive all standard-of-care cancer treatment and cardiac monitoring as determined by their clinical care team.

The primary outcome is incident atrial or ventricular arrhythmia detected during the study. Secondary outcomes include the association between heart sounds and echocardiographic findings of systolic or diastolic dysfunction, and the association between heart sounds and cardiac laboratory markers such as high-sensitivity troponin I and NT-proBNP.

02

Conditions studied

  • Cardiotoxicity
  • Cancer
  • Cardiac Arrhythmia
  • Left Ventricular Dysfunction
  • Breast Cancer
  • Multiple Myeloma

Keywords

  • MCT-WAVE
  • Mobile cardiac telemetry
  • Wearable cardiac monitor
  • Cardio-oncology
  • Ventricular arrhythmia
  • Breast cancer
03

In context

Cardiotoxicity

262 studies on the registry are indexed under Cardiotoxicity; 75 are open to participants now.

This study's planned enrollment of 72 is below the median of 93 across 137 interventional studies indexed under Cardiotoxicity.

Browse Cardiotoxicity studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.

Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of breast cancer, hematologic including leukemia or lymphoma, or multiple myeloma
  • At least 18 years of age
  • Capable of understanding and willing to sign a consent form for this study

Exclusion criteria

Exclusion Criteria:

  • Known allergy to adhesive patches used for ambulatory monitoring
  • Children
  • Cognitively challenged individuals
  • Prisoners
  • Active service military personnel
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
72 participants (estimated)

Study 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.

    Device: Mobile Cardiac Telemetry · Device: Wearable Cardiac Monitor

Interventions

  • DeviceMobile Cardiac Telemetry

    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.

    Also known as: BodyGuardian Mini Plus

  • DeviceWearable Cardiac Monitor

    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.

    Also known as: WCM

06

What researchers measure

Primary outcomes

  1. Incident Atrial or Ventricular Arrhythmia

    Incident atrial or ventricular arrhythmia detected by mobile cardiac telemetry during and following cancer treatment will be assessed.

    Time frame: Up to 12 months

Secondary outcomes

  1. Correlation Between Wearable Cardiac Monitor Heart Sound Measures and High-Sensitivity Troponin I

    Correlation between heart sound measures collected by the wearable cardiac monitor and high-sensitivity troponin I concentration during the study period.

    Time frame: Up to 12 months

  2. Correlation Between Wearable Cardiac Monitor Heart Sound Measures and NT-proBNP

    Correlation between heart sound measures collected by the wearable cardiac monitor and NT-proBNP concentration during the study period.

    Time frame: Up to 12 months

  3. Correlation Between Wearable Cardiac Monitor Heart Sound Measures and Left Ventricular Ejection Fraction

    Correlation between heart sound measures collected by the wearable cardiac monitor and left ventricular ejection fraction measured by echocardiography during the study period.

    Time frame: Up to 12 months

  4. Correlation Between Wearable Cardiac Monitor Heart Sound Measures and Echocardiographic Measures of Diastolic Function

    Correlation between heart sound measures collected by the wearable cardiac monitor and echocardiographic measures of diastolic function during the study period.

    Time frame: Up to 12 months

07

Study locations

1 site
08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Mar 2028, 15 months later.

Of 48 non-industry interventional studies with no phase under Cardiotoxicity, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 73. This study's planned 15 months is below that.

Counting every sponsor, half of 48 studies reached it within 52 months; a quarter within 35 and three quarters within 73.

Start moved twice since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, last on Nov 2, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2026
First posted
Aug 20, 2026
StartEst.
Dec 1, 2026was Sep 2026
Primary completionEst.
Mar 1, 2028
CompletionEst.
Sep 1, 2028
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 15, 2026→Dec 1, 2026
moved 2 times, Oct 6, 2026 – Nov 2, 2026
Show all 2 updates
  1. Nov 2, 2026
    Start date Oct 29, 2026→Dec 1, 2026
  2. Oct 6, 2026
    Start date Sep 15, 2026→Oct 29, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07776964
Responsible party
Sponsor
First posted
Aug 20, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Mar 1, 2028 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Nov 2, 2026

Study contacts

Suma Konety, MD
Contact
shkonety@umn.edu
612-625-4465
Samantha Wansing
Contact
hoppx054@umn.edu
612-625-4465
Suma Konety, MD
principal investigator · University of Minnesota

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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