Atrial FibrillationIRAF-ISCMNCT06029166
Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors
A study testing Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®) in people with Atrial Fibrillation, run by University Hospital, Caen at 1 site in France.
Trial 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 kinase (BTK) inhibitor (ibrutinib, acalabrutinib, zanubrutinib) using an insertable subcutaneous cardiac monitor (ISCM)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2023to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Caen University Hospital, Department of Pharmacology
Caen, Normandy
Joachim ALEXANDRE, MDPHD, 0231064671, alexandre-j@chu-caen.fr
About this study
Official title: Electrocardiographic Changes and Rhythm Disorders Associated With BTK Inhibitors Exposure Using an Insertable Subcutaneous Cardiac Monitor: a Multicenter Cardio-Oncology Prospective Cohort
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®)
- Keywords
- cardio-oncology, cardiotoxicity, hematologic malignancy, atrial fibrillation, rhythm disorders, insertable subcutaneous cardiac monitor
- Medical subject headings
- Atrial Fibrillation, Cardiotoxicity, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®)Device
Implantation of a subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®) before beginning the Bruton's tyrosine kinase inhibitor treatment.
| Study group | Role | What they receive |
|---|---|---|
| Hematologic malignancy patients requiring a treatment by Bruton's tyrosine kinase inhibitor | Other | 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). Receives: Device: Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any electrocardiographic changes and/or rhythm disorders from first BTK inhibitors prescription to 12 months of follow-up, symptomatic or not, detected on 12-lead ECG and/or on ISCM.
Electrocardiographic changes and/or rhythm disorders are defined by the European Society of Cardiology guidelines.
Measured: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Secondary outcomes (9)
Electrocardiographic intervals (PR, QRS, QT) measurements on both 12-lead ECG and ISCM at baseline and with BTK inhibitors exposure.
Measured: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
The occurrence of bleeding events from inclusion and within 12 months.
Measured: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Correlation between IRAF and multiple demographic, clinical, cardiac imaging (morphological data) and serum cardiac biomarkers.
Measured: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
IRAF management.
Measured: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Progression-free survival of patients treated by BTK inhibitors according to the presence of IRAF.
Measured: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Correlation between QT/QTc measurements performed by ISCM (BIOMONITOR IIIm®, Biotronik®) and a QT expert on 12-leads ECG.
Measured: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Daily body temperature monitoring with the ISCM (BIOMONITOR IIIm®, Biotronik®) temperature sensor and will be compared with conventional body temperature measurements performed during follow-up visits.
Measured: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Constitute a plasmatic biobank for futures ancillary studies.
Measured: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
The need for ISCM (BIOMONITOR IIIm®, Biotronik®) remove within the 12-months follow-up.
Measured: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029166
- Sponsor's protocol ID
- 22-0252
- Acronym
- IRAF-ISCM
- Status last verified
- Jul 2023
- First submitted
- 28 Aug 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocardiographic Changes and Rhythm Disorders Associated With BTK Inhibitors Exposure Using an Insertable Subcutaneous Cardiac Monitor: a Multicenter Cardio-Oncology Prospective Cohort
- ClinicalTrials.gov ID
- NCT06029166
- Acronym / sponsor ID
- IRAF-ISCM / 22-0252
- Conditions
- Atrial Fibrillation
- Keywords
- cardio-oncology, cardiotoxicity, hematologic malignancy, atrial fibrillation, rhythm disorders, insertable subcutaneous cardiac monitor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- 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
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hematologic malignancy patients requiring a treatment by Bruton's tyrosine kinase inhibitor | Other | Device: Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Hematologic malignancy patients requiring a treatment by Bruton's tyrosine kinase inhibitor |
Primary outcome
Occurrence of any electrocardiographic changes and/or rhythm disorders from first BTK inhibitors prescription to 12 months of follow-up, symptomatic or not, detected on 12-lead ECG and/or on ISCM.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Electrocardiographic changes and/or rhythm disorders are defined by the European Society of Cardiology guidelines.
9 secondary outcomes
Electrocardiographic intervals (PR, QRS, QT) measurements on both 12-lead ECG and ISCM at baseline and with BTK inhibitors exposure.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
The occurrence of bleeding events from inclusion and within 12 months.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Correlation between IRAF and multiple demographic, clinical, cardiac imaging (morphological data) and serum cardiac biomarkers.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
IRAF management.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Progression-free survival of patients treated by BTK inhibitors according to the presence of IRAF.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Correlation between QT/QTc measurements performed by ISCM (BIOMONITOR IIIm®, Biotronik®) and a QT expert on 12-leads ECG.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Daily body temperature monitoring with the ISCM (BIOMONITOR IIIm®, Biotronik®) temperature sensor and will be compared with conventional body temperature measurements performed during follow-up visits.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Constitute a plasmatic biobank for futures ancillary studies.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
The need for ISCM (BIOMONITOR IIIm®, Biotronik®) remove within the 12-months follow-up.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®) in people with Atrial Fibrillation, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joachim Alexandre, MD, PhD (+33 2.31.06.46.71, alexandre-j@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of any electrocardiographic changes and/or rhythm disorders from first BTK inhibitors prescription to 12 months of follow-up, symptomatic or not, detected on 12-lead ECG and/or on ISCM. (time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.