Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors
NCT ID: NCT06029166
Last Updated: 2023-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2023-10-01
2026-10-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Marseille
OTHER
Groupe Hospitalier Pitie-Salpetriere
OTHER
European Georges Pompidou Hospital
OTHER
Hôpital Necker-Enfants Malades
OTHER
Saint Antoine University Hospital
OTHER
Hospices Civils de Lyon
OTHER
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Biotronik SE & Co. KG
INDUSTRY
University Hospital, Caen
OTHER
Responsible Party
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Locations
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Caen University Hospital, Department of Pharmacology
Caen, Normandy, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-0252
Identifier Type: -
Identifier Source: org_study_id
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