BTKi-induced Atrial FibrillationNCT06130709
IRAF-ABLATION Study: a Multicenter International Retrospective Cohort of Patients With BTK Inhibitors-related AF Treated by Catheter Ablation
An observational study of BTKi-induced Atrial Fibrillation and Hematologic Malignancy, run by University Hospital, Caen at 1 site in France.
Trial summary
Targeted anticancer drugs have completely changed the prognosis of malignancies during the past decades. Patients suffering from malignancies live longer and this allows adverse events of anticancer drugs to emerge, notably cardiovascular adverse events. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- BTKi-induced Atrial Fibrillation, Hematologic Malignancy, Atrial Fibrillation Catheter Ablation
- What is being tested?
- Atrial fibrillation catheter ablation in a population of BTKi-induced atrial fibrillation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2023to 1 Jun 2025
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult population treated with iBTK for hematologic malignancy and who developped BTKi-induced atrial fibrillation treated by cathter ablation.
Who may be able to join
- every adult patient treated by BTKi for a hematological malignancy
- with a new onset recurrence of AF occurring after BTKi initiation and treated by catheter ablation
- with an available 12 months follow up after catheter ablation
Who cannot join
- Patients younger than 18 years old
- Severe mitral regurgitation/stenosis or rhumatismal heart disease whatever the grade
- Permanent AF
- Patient who had AF rhythm during the first administration of BTKi
Trial locations and contacts
1 site in 1 country.
France1 site
Caen University Hospital
Caen, Normandy, 14000
Joachim ALEXANDRE, MD, PhD, +330231064770, alexandre-j@chu-caen.fr
Joachim ALEXANDRE, MD, PhD
About this study
Targeted anticancer drugs have completely changed the prognosis of malignancies during the past decades. Patients suffering from malignancies live longer and this allows adverse events of anticancer drugs to emerge, notably cardiovascular adverse events. It is particularly important because of the great morbimortality of major cardiovascular events like myocardial infarction or stroke and because of their frequency in cancer populations. Indeed, cardiovascular death is the second cause of deaths after malignancy itself in this population. Atrial fibrillation (AF) is a non rare cardiovascular adverse events associated with a shorter overall survival in some malignancies localization. The emblematic anticancer drugs promoting AF is ibrutinib belonging to the Bruton tyrosine kinase inhibitors (BTKi), which are indicated in hematological malignancies. Incidence of AF with ibrutinib is estimated to 4.92/100 person-years; 95% CI: 2.91-4.81 but is underestimated because of the absence of systematic electrocardiogram recording. The management of AF rests on anticoagulation if indicated by the CHA2DS2-VASc score, and on the choice between a rate or rhythm control strategy. Rate control is the privileged strategy because of the risk of drugs interactions of the anti-arrhythmic drugs in a context of anticancer drugs co-prescriptions. But in case of symptoms with normal heart rate, life expectancy counted in years and preserved condition, catheter ablation has to be discussed. Whereas this interventional procedure has been greatly studied in the general population, no study exists in patients with hematological malignancies. The investigators aim to describe baseline characteristics of a population of BTKi-induced AF undergone AF catheter ablation.
Read the detailed description
Targeted anticancer drugs have completely changed the prognosis of malignancies during the past decades. Patients suffering from malignancies live longer and this allows adverse events of anticancer drugs to emerge, notably cardiovascular adverse events. It is particularly important because of the great morbimortality of major cardiovascular events like myocardial infarction or stroke and because of their frequency in cancer populations. Indeed, cardiovascular death is the second cause of deaths after malignancy itself in this population. Atrial fibrillation (AF) is a non rare cardiovascular adverse events associated with a shorter overall survival in some malignancies localization. The emblematic anticancer drugs promoting AF is ibrutinib belonging to the Bruton tyrosine kinase inhibitors (BTKi), which are indicated in hematological malignancies. Incidence of AF with ibrutinib is estimated to 4.92/100 person-years; 95% CI: 2.91-4.81 but is underestimated because of the absence of systematic electrocardiogram recording. The management of AF rests on anticoagulation if indicated by the CHA2DS2-VASc score, and on the choice between a rate or rhythm control strategy. Rate control is the privileged strategy because of the risk of drugs interactions of the anti-arrhythmic drugs in a context of anticancer drugs co-prescriptions. But in case of symptoms with normal heart rate, life expectancy counted in years and preserved condition, catheter ablation has to be discussed. Whereas this interventional procedure has been greatly studied in the general population, no study exists in patients with hematological malignancies. The investigators aim to describe baseline characteristics of a population of BTKi-induced AF undergone AF catheter ablation.
- Conditions
- BTKi-induced Atrial Fibrillation, Hematologic Malignancy, Atrial Fibrillation Catheter Ablation
- Being tested
- Atrial fibrillation catheter ablation in a population of BTKi-induced atrial fibrillation
- Keywords
- atrial fibrillation, Bruton tyrosine kinase inhibitors, catheter ablation,, atrial fibrillation recurrence
- Medical subject headings
- Hematologic Neoplasms, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial fibrillation catheter ablation in a population of BTKi-induced atrial fibrillationProcedure or surgery
Atrial fibrillation catheter ablation in a population of BTKi-induced atrial fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the one-year AF recurrence rate after catheter ablation in a population of BTKi induced AF
AF recurrence is defined as atrial fibrillation or atrial tachycardia or atrial flutter, on a single 12-lead ECG or lasting more than 30 seconds on Holter monitoring in the period between the end of the 3-month blanking period and 12-month follow-up.
Measured: 1 year follow-up from the catheter ablation date
Secondary outcomes (4)
Description of the baseline characteristic of the population of BTKi induced AF with AF catheter ablation carried out
Measured: At inclusion (= the time of ablation date)
Description of atrial electrophysiological properties during AF catheter ablation in a population of BTKi induced AF
Measured: At inclusion (= the time of ablation date)
Description of AF catheter ablation complications at 3 months follow-up in a population of BTKi induced AF (MACE, sepsis, bleeding, hospitalization prolongation, hospitalization readmission, mortality)
Measured: 3 months follow-up from the ablation date
Identification of baseline parameters and electrophysiologic parameters associated with AF recurrence at 12 months follow-up
Measured: 1 year follow-up from the catheter ablation date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BTKi-induced 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joachim ALEXANDRE, MD, PhD, Principal investigator, Caen Normandy University Hospital, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130709
- Sponsor's protocol ID
- IRAF-Ablation
- Status last verified
- Oct 2023
- First submitted
- 6 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alexandre J, Salem JE, Moslehi J, Sassier M, Ropert C, Cautela J, Thuny F, Ederhy S, Cohen A, Damaj G, Vilque JP, Plane AF, Legallois D, Champ-Rigot L, Milliez P, Funck-Brentano C, Dolladille C. Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance database. Eur Heart J Cardiovasc Pharmacother. 2021 Jul 23;7(4):312-320. doi: 10.1093/ehjcvp/pvaa037.
PubMed 32353110Lyon AR, Lopez-Fernandez T, Couch LS, Asteggiano R, Aznar MC, Bergler-Klein J, Boriani G, Cardinale D, Cordoba R, Cosyns B, Cutter DJ, de Azambuja E, de Boer RA, Dent SF, Farmakis D, Gevaert SA, Gorog DA, Herrmann J, Lenihan D, Moslehi J, Moura B, Salinger SS, Stephens R, Suter TM, Szmit S, Tamargo J, Thavendiranathan P, Tocchetti CG, van der Meer P, van der Pal HJH; ESC Scientific Document Group. 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS). Eur Heart J. 2022 Nov 1;43(41):4229-4361. doi: 10.1093/eurheartj/ehac244. No abstract available.
PubMed 36017568Agarwal S, Munir MB, Krishan S, Yang EH, Barac A, Asad ZUA. Outcomes and readmissions in patients with cancer undergoing catheter ablation for atrial fibrillation. Europace. 2023 Aug 2;25(9):euad263. doi: 10.1093/europace/euad263. No abstract available.
PubMed 37655932
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IRAF-ABLATION Study: a Multicenter International Retrospective Cohort of Patients With BTK Inhibitors-related AF Treated by Catheter Ablation
- ClinicalTrials.gov ID
- NCT06130709
- Acronym / sponsor ID
- IRAF-Ablation
- Conditions
- BTKi-induced Atrial Fibrillation, Hematologic Malignancy, Atrial Fibrillation Catheter Ablation
- Keywords
- atrial fibrillation, Bruton tyrosine kinase inhibitors, catheter ablation,, atrial fibrillation recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 14 Nov 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.
Targeted anticancer drugs have completely changed the prognosis of malignancies during the past decades. Patients suffering from malignancies live longer and this allows adverse events of anticancer drugs to emerge, notably cardiovascular adverse events. It is particularly important because of the great morbimortality of major cardiovascular events like myocardial infarction or stroke and because of their frequency in cancer populations. Indeed, cardiovascular death is the second cause of deaths after malignancy itself in this population. Atrial fibrillation (AF) is a non rare cardiovascular adverse events associated with a shorter overall survival in some malignancies localization. The emblematic anticancer drugs promoting AF is ibrutinib belonging to the Bruton tyrosine kinase inhibitors (BTKi), which are indicated in hematological malignancies. Incidence of AF with ibrutinib is estimated to 4.92/100 person-years; 95% CI: 2.91-4.81 but is underestimated because of the absence of systematic electrocardiogram recording. The management of AF rests on anticoagulation if indicated by the CHA2DS2-VASc score, and on the choice between a rate or rhythm control strategy. Rate control is the privileged strategy because of the risk of drugs interactions of the anti-arrhythmic drugs in a context of anticancer drugs co-prescriptions. But in case of symptoms with normal heart rate, life expectancy counted in years and preserved condition, catheter ablation has to be discussed. Whereas this interventional procedure has been greatly studied in the general population, no study exists in patients with hematological malignancies. The investigators aim to describe baseline characteristics of a population of BTKi-induced AF undergone AF catheter ablation.
Detailed description
Targeted anticancer drugs have completely changed the prognosis of malignancies during the past decades. Patients suffering from malignancies live longer and this allows adverse events of anticancer drugs to emerge, notably cardiovascular adverse events. It is particularly important because of the great morbimortality of major cardiovascular events like myocardial infarction or stroke and because of their frequency in cancer populations. Indeed, cardiovascular death is the second cause of deaths after malignancy itself in this population. Atrial fibrillation (AF) is a non rare cardiovascular adverse events associated with a shorter overall survival in some malignancies localization. The emblematic anticancer drugs promoting AF is ibrutinib belonging to the Bruton tyrosine kinase inhibitors (BTKi), which are indicated in hematological malignancies. Incidence of AF with ibrutinib is estimated to 4.92/100 person-years; 95% CI: 2.91-4.81 but is underestimated because of the absence of systematic electrocardiogram recording. The management of AF rests on anticoagulation if indicated by the CHA2DS2-VASc score, and on the choice between a rate or rhythm control strategy. Rate control is the privileged strategy because of the risk of drugs interactions of the anti-arrhythmic drugs in a context of anticancer drugs co-prescriptions. But in case of symptoms with normal heart rate, life expectancy counted in years and preserved condition, catheter ablation has to be discussed. Whereas this interventional procedure has been greatly studied in the general population, no study exists in patients with hematological malignancies. The investigators aim to describe baseline characteristics of a population of BTKi-induced AF undergone AF catheter ablation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population treated with iBTK for hematologic malignancy and who developped BTKi-induced atrial fibrillation treated by cathter ablation.
Key inclusion criteria (3 listed)
- every adult patient treated by BTKi for a hematological malignancy
- with a new onset recurrence of AF occurring after BTKi initiation and treated by catheter ablation
- with an available 12 months follow up after catheter ablation
Key exclusion criteria (4 listed)
- Patients younger than 18 years old
- Severe mitral regurgitation/stenosis or rhumatismal heart disease whatever the grade
- Permanent AF
- Patient who had AF rhythm during the first administration of BTKi
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 |
|---|---|---|
| Atrial fibrillation catheter ablation in a population of BTKi-induced atrial fibrillationAtrial fibrillation catheter ablation in a population of BTKi-induced atrial fibrillation | Procedure or surgery | – |
Primary outcome
Description of the one-year AF recurrence rate after catheter ablation in a population of BTKi induced AF
Time frame: 1 year follow-up from the catheter ablation date
AF recurrence is defined as atrial fibrillation or atrial tachycardia or atrial flutter, on a single 12-lead ECG or lasting more than 30 seconds on Holter monitoring in the period between the end of the 3-month blanking period and 12-month follow-up.
4 secondary outcomes
Description of the baseline characteristic of the population of BTKi induced AF with AF catheter ablation carried out
Time frame: At inclusion (= the time of ablation date)
Description of atrial electrophysiological properties during AF catheter ablation in a population of BTKi induced AF
Time frame: At inclusion (= the time of ablation date)
Description of AF catheter ablation complications at 3 months follow-up in a population of BTKi induced AF (MACE, sepsis, bleeding, hospitalization prolongation, hospitalization readmission, mortality)
Time frame: 3 months follow-up from the ablation date
Identification of baseline parameters and electrophysiologic parameters associated with AF recurrence at 12 months follow-up
Time frame: 1 year follow-up from the catheter ablation date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 32353110Alexandre J, Salem JE, Moslehi J, Sassier M, Ropert C, Cautela J, Thuny F, Ederhy S, Cohen A, Damaj G, Vilque JP, Plane AF, Legallois D, Champ-Rigot L, Milliez P, Funck-Brentano C, Dolladille C. Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance database. Eur Heart J Cardiovasc Pharmacother. 2021 Jul 23;7(4):312-320. doi: 10.1093/ehjcvp/pvaa037.
- Background: PubMed 36017568Lyon AR, Lopez-Fernandez T, Couch LS, Asteggiano R, Aznar MC, Bergler-Klein J, Boriani G, Cardinale D, Cordoba R, Cosyns B, Cutter DJ, de Azambuja E, de Boer RA, Dent SF, Farmakis D, Gevaert SA, Gorog DA, Herrmann J, Lenihan D, Moslehi J, Moura B, Salinger SS, Stephens R, Suter TM, Szmit S, Tamargo J, Thavendiranathan P, Tocchetti CG, van der Meer P, van der Pal HJH; ESC Scientific Document Group. 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS). Eur Heart J. 2022 Nov 1;43(41):4229-4361. doi: 10.1093/eurheartj/ehac244. No abstract available.
- Results publication: PubMed 37655932Agarwal S, Munir MB, Krishan S, Yang EH, Barac A, Asad ZUA. Outcomes and readmissions in patients with cancer undergoing catheter ablation for atrial fibrillation. Europace. 2023 Aug 2;25(9):euad263. doi: 10.1093/europace/euad263. No abstract available.
- Individual participant dataSharing planned: No
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.
Joachim ALEXANDRE, MD, PhD principal investigator
Caen Normandy University Hospital, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BTKi-induced Atrial Fibrillation and Hematologic Malignancy, 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 3 inclusion and 4 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 14 Nov 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 (+330231064770, 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?
Description of the one-year AF recurrence rate after catheter ablation in a population of BTKi induced AF (time frame: 1 year follow-up from the catheter ablation date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06130709, which also lists 3 linked publications.
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 14 Nov 2023.