Last updated: September 6, 2023
Sponsor: University Hospital, Caen
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Chest Pain
Cardiac Disease
Dysrhythmia
Treatment
Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®)
Clinical Study ID
NCT06029166
22-0252
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adult patients,
- Definite diagnosis of hematologic malignancy requiring a BTK inhibition withibrutinib, 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 outlinedin the protocol
Exclusion
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 asdefined 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-defibrillatorat 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.
Study Design
Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®)
Phase:
Study Start date:
October 01, 2023
Estimated Completion Date:
October 01, 2026
Connect with a study center
Caen University Hospital, Department of Pharmacology
Caen, Normandie
FranceSite Not Available
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