Status:
NOT_YET_RECRUITING
Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors
Lead Sponsor:
University Hospital, Caen
Collaborating Sponsors:
University Hospital, Marseille
Groupe Hospitalier Pitie-Salpetriere
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 k...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06029166
Start Date
October 1 2023
End Date
October 1 2026
Last Update
September 8 2023
Active Locations (1)
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1
Caen University Hospital, Department of Pharmacology
Caen, Normandy, France