Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT06029166
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06029166
Study Brief:
Protocol Section:
NCT06029166