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

NCT07776964 | Not Yet Recruiting FDA Device

• 1 other identifier: CV-2025-33755
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

  Up to 12 months

Secondary Outcomes (4)

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

  Up to 12 months

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

  Up to 12 months

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

  Up to 12 months

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

  Up to 12 months

Study Arms (1)

Mobile Cardiac Telemetry and Wearable Cardiac Monitor With Usual Care

EXPERIMENTAL

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

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.

Also known as: BodyGuardian Mini Plus

Mobile Cardiac Telemetry and Wearable Cardiac Monitor With Usual Care

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.

Also known as: WCM

Mobile Cardiac Telemetry and Wearable Cardiac Monitor With Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of breast cancer, hematologic malignancy 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

You may not qualify if:

• Known allergy to adhesive patches used for ambulatory EKG monitoring
• Children
• Cognitively challenged individuals
• Prisoners
• Active service military personnel

Sponsors & Collaborators

• University of Minnesota: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

M Health Fairview Clinics and Surgery Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Cardiotoxicity; Neoplasms; Arrhythmias, Cardiac; Ventricular Dysfunction, Left; Breast Neoplasms; Multiple Myeloma

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Ventricular Dysfunction; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Suma Konety, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suma Konety, MD

CONTACT

612-625-4465; shkonety@umn.edu

Samantha Wansing

CONTACT

612-625-4465; hoppx054@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 20, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

US (1)