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Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors

Study acronym: IRAF-ISCM
StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 8, 2023 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Jul 2023); last known: Not Yet Recruiting
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
(from sponsor)		 Atrial Fibrillation
Related terms Atrial Fibrillation, Cardiotoxicity, Hematologic Neoplasms
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov