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

Hematologic Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06130709
• Other study ID #: IRAF-Ablation
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: October 2023
• Source: University Hospital, Caen
• Contact: Joachim ALEXANDRE, MD, PhD
• Phone: +330231064770
• Email: alexandre-j[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hematologic Malignancy
• Hematologic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Caen University Hospital	Caen	Normandy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (3)

Agarwal 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. — View Citation

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. — View Citation

Lyon 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. Erratum In: Eur Heart J. 2023 May 7;44(18):1621. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year follow-up from the catheter ablation date
Secondary	Description of the baseline characteristic of the population of BTKi induced AF with AF catheter ablation carried out		At inclusion (= the time of ablation date)
Secondary	Description of atrial electrophysiological properties during AF catheter ablation in a population of BTKi induced AF		At inclusion (= the time of ablation date)
Secondary	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
Secondary	Identification of baseline parameters and electrophysiologic parameters associated with AF recurrence at 12 months follow-up		1 year follow-up from the catheter ablation date