MedTrace Logo

Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors

NCT06029166 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-09-08

No results posted yet for this study

Summary

The goal of this clinical trial is to screen all types of electrocardiographic changes and rhythm disorders in adult patients with a hematologic malignancy requiring a treatment by Bruton's tyrosine kinase (BTK) inhibitor (ibrutinib, acalabrutinib, zanubrutinib) using an insertable subcutaneous cardiac monitor (ISCM) and occurring from inclusion and within 12 months.

This study consists of the implantation of an ISCM at inclusion and before BTK inhibitor initiation. Then patients will have medical visits every 3 months (+/- 7 days) during 12 months and a continuous cardiac telemonitoring using the ISCM.

Conditions

Interventions

DEVICE

Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®)

Implantation of a subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®) before beginning the Bruton's tyrosine kinase inhibitor treatment.

Sponsors & Collaborators

  • University Hospital, Marseille

    collaborator OTHER

  • Groupe Hospitalier Pitie-Salpetriere

    collaborator OTHER

  • European Georges Pompidou Hospital

    collaborator OTHER

  • Hôpital Necker-Enfants Malades

    collaborator OTHER

  • Saint Antoine University Hospital

    collaborator OTHER

  • Hospices Civils de Lyon

    collaborator OTHER

  • Centre Hospitalier Universitaire de Saint Etienne

    collaborator OTHER

  • Biotronik SE & Co. KG

    collaborator INDUSTRY

  • University Hospital, Caen

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2026-10-01
Completion
2026-10-01

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06029166 on ClinicalTrials.gov