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Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors
Sponsor: University Hospital, Caen
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
Conditions
Interventions
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