Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors (IRAF-ISCM)
Atrial Fibrillation
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring cardio-oncology, cardiotoxicity, hematologic malignancy, atrial fibrillation, rhythm disorders, insertable subcutaneous cardiac monitor
Eligibility Criteria
Inclusion Criteria: Adult patients, Definite diagnosis of hematologic malignancy requiring a BTK inhibition with ibrutinib, acalabrutinib or zanubrutinib, Expected BTK inhibitor duration estimated to be at least 12 months, Sinus rhythm at enrolment, Willing to sign patient consent form and to comply with scheduled visits, as outlined in the protocol Exclusion Criteria: Age < 18 years old, Adults with protective measures (curatorship or tutorship) and vulnerable patients, Pregnant or nursing women, Permanent atrial fibrillation or long-standing persistent atrial fibrillation as defined by the European Society of Cardiology guidelines, Atrial fibrillation on the electrocardiogram at the inclusion visit, Previous left atrial ablation or previous maze or maze-like surgery, Indication for or patients with a pacemaker or implantable cardioverter-defibrillator at baseline, Untreated hyperthyroidism, Uncorrected kaliaemia disorders at the inclusion visit, Hemoglobin < 8 g/L at the inclusion visit, Thrombopenia < 50,000/mm3 at the inclusion visit, Active bleeding, Myocardial infarction < 1 month, Surgery < 1 month, Mechanical heart valve, Valvular heart disease requiring surgery, Inability to follow the required procedures of the clinical investigation plan, No signature of patient consent form.
Sites / Locations
- Caen University Hospital, Department of Pharmacology
Arms of the Study
Arm 1
Other
Hematologic malignancy patients requiring a treatment by Bruton's tyrosine kinase inhibitor
Consecutive adult patients with a definite diagnosis of hematologic malignancy requiring a treatment by Bruton's tyrosine kinase (BTK) inhibitor (ibrutinib, acalabrutinib, zanubrutinib) during at least 12 months will be included to receive an insertable subcutaneous cardiac monitor (ISCM).