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

November 10, 2023 updated by: University Hospital, Caen
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Normandy
      • Caen, Normandy, France, 14000
        • CAEN University Hospital
        • Principal Investigator:
          • Joachim ALEXANDRE, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Jonaz FONT, MD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult population treated with iBTK for hematologic malignancy and who developped BTKi-induced atrial fibrillation treated by cathter ablation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year follow-up from the catheter ablation date

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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
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
1 year follow-up from the catheter ablation date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Joachim ALEXANDRE, MD, PhD, Caen Normandy University Hospital, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

November 6, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Estimated)

November 14, 2023

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAF-Ablation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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