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Trial Title:
IRAF-ABLATION Study: a Multicenter International Retrospective Cohort of Patients With BTK Inhibitors-related AF Treated by Catheter Ablation
NCT ID:
NCT06130709
Condition:
BTKi-induced Atrial Fibrillation
Hematologic Malignancy
Atrial Fibrillation Catheter Ablation
Conditions: Official terms:
Hematologic Neoplasms
Atrial Fibrillation
Conditions: Keywords:
atrial fibrillation
Bruton tyrosine kinase inhibitors
catheter ablation,
atrial fibrillation recurrence
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
Atrial fibrillation catheter ablation in a population of BTKi-induced atrial fibrillation
Description:
Atrial fibrillation catheter ablation in a population of BTKi-induced atrial fibrillation
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. 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.
Criteria for eligibility:
Study pop:
Adult population treated with iBTK for hematologic malignancy and who developped
BTKi-induced atrial fibrillation treated by cathter ablation.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Caen University Hospital
Address:
City:
Caen
Zip:
14000
Country:
France
Contact:
Last name:
Joachim ALEXANDRE, MD, PhD
Phone:
+330231064770
Email:
alexandre-j@chu-caen.fr
Investigator:
Last name:
Joachim ALEXANDRE, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Jonaz FONT, MD, MSc
Email:
Sub-Investigator
Start date:
December 1, 2023
Completion date:
June 1, 2025
Lead sponsor:
Agency:
University Hospital, Caen
Agency class:
Other
Source:
University Hospital, Caen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06130709
