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IRAF-ABLATION Study: a Multicenter International Retrospective Cohort of Patients With BTK Inhibitors-related AF Treated by Catheter Ablation

IRAF-ABLATION Study: a Multicenter International Retrospective Cohort of Patients With BTK Inhibitors-related AF Treated by Catheter Ablation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06130709
Enrollment
100
Registered
2023-11-14
Start date
2023-12-01
Completion date
2025-06-01
Last updated
2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation Catheter Ablation, BTKi-induced Atrial Fibrillation, Hematologic Malignancy

Keywords

atrial fibrillation, Bruton tyrosine kinase inhibitors, catheter ablation,, atrial fibrillation recurrence

Brief 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.

Interventions

PROCEDUREAtrial fibrillation catheter ablation in a population of BTKi-induced atrial fibrillation

Atrial fibrillation catheter ablation in a population of BTKi-induced atrial fibrillation

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Description of the one-year AF recurrence rate after catheter ablation in a population of BTKi induced AF1 year follow-up from the catheter ablation dateAF 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.

Secondary

MeasureTime frame
Description of the baseline characteristic of the population of BTKi induced AF with AF catheter ablation carried outAt inclusion (= the time of ablation date)
Description of atrial electrophysiological properties during AF catheter ablation in a population of BTKi induced AFAt 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)3 months follow-up from the ablation date
Identification of baseline parameters and electrophysiologic parameters associated with AF recurrence at 12 months follow-up1 year follow-up from the catheter ablation date

Countries

France

Contacts

Primary ContactJoachim ALEXANDRE, MD, PhD
alexandre-j@chu-caen.fr+330231064770

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026