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NOT YET RECRUITING
NCT06029166
NA

Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors

Sponsor: University Hospital, Caen

View on ClinicalTrials.gov

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.

Official title: Electrocardiographic Changes and Rhythm Disorders Associated With BTK Inhibitors Exposure Using an Insertable Subcutaneous Cardiac Monitor: a Multicenter Cardio-Oncology Prospective Cohort

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-10-01

Completion Date

2026-10-01

Last Updated

2023-09-08

Healthy Volunteers

No

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.

Locations (1)

Caen University Hospital, Department of Pharmacology

Caen, Normandy, France