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NCT06029166 · ClinicalTrials.gov record · last posted 2023-09-08

Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors

Name: Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors — clinical trial record (NCT06029166)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: IRAF-ISCM

StatusNot Yet Recruiting

PhaseNot applicable

SponsorUniversity Hospital, Caen

Started2023-10-01

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

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 kinase (BTK) inhibitor (ibrutinib, acalabrutinib, zanubrutinib) using an insertable subcutaneous cardiac monitor (ISCM) and occurring from inclusion and within 12 months. 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.

Trial Details

NCT Number	NCT06029166
Lead Sponsor	University Hospital, Caen Collaborators: University Hospital, Marseille, Groupe Hospitalier Pitie-Salpetriere, European Georges Pompidou Hospital, Hôpital Necker-Enfants Malades, Saint Antoine University Hospital, Hospices Civils de Lyon, Centre Hospitalier Universitaire de Saint Etienne, Biotronik SE & Co. KG
Conditions	Atrial Fibrillation
Enrollment	100 participants
Start Date	2023-10-01
Primary Completion	2026-10-01 (estimated)
Study Completion	2026-10-01 (estimated)
Updated on ClinicalTrials.gov	2023-09-08