Italian Registry In the Setting of AF Ablation With Rivaroxaban (IRIS)

Study Overview
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Brief Summary
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The aim of IRIS study is to observe the safety and efficacy of Rivaroxaban in subjects undergoing catheter ablation for atrial fibrillation (AF) in real-world clinical practice. The transcatheter ablation of AF is now considered an essential therapeutic strategy in the management of patients with this arrhythmia. In fact, it is known how fibrillating patients have a greater risk to develop thromboembolic phenomena; this risk can also increase during ablation (risk intrinsically with the procedure), therefore a careful anti-coagulant therapy is fundamental to avoid the formation of new thrombus and their dissemination through blood circulation. The use of direct oral anti-coagulants (DOAC) in the fibrillating patient has been revealed a more safe and effective approach if compared with the standard therapy (direct vitamin K antagonists, VKA). In the specific case of the Rivaroxaban, several experimental trials have shown how the uninterrupted administration of the drug before the ablation procedure is safe and valid. However, little information related to its use in the daily clinical assistance activity is still known and no real-life data are available for the Italian context. Moreover, in Italy the uninterrupted strategy is not commonly used, and physicians often adopt the short interruption strategy. Thus, the IRIS registry is aimed to collect new real-life data by collecting not only information regarding the effectiveness and safety of the drug, but also regarding the type of strategy (short interruption or uninterrupted strategy) used by the Italian centers participating to this study.

Detailed Description
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IRIS study is an Italian, multicenter, prospective and non-interventional study aimed to observe the safety and efficacy of uninterrupted or shortly interrupted catheter ablation procedure with Rivaroxaban in nonvalvular atrial fibrillation (NVAF) patients in real-world clinical practice. 250 patients treated with rivaroxaban undergoing AF-ablation procedure are expected to be enrolled in two years. The patients can arrive already taking rivaroxaban or if they are naïve, the investigators will start the therapy and taking rivaroxaban for at least 4 weeks. The decision to prescribe rivaroxaban is under discretion of the treating physician, including the dose and duration of therapy. Also the decision on the ablation technique and energy used during the procedure (radiofrequency catheter ablation or Cryoballoon Ablation) is up to the investigators. Because this study is intended to assess the use of rivaroxaban in routine real-world clinical practice, study protocol will not interfere with the clinical management of patients or with the prescribing behaviors of attending physicians. IRIS study will include all consenting patients and collect data at the following time points: One inclusion/exclusion visit at the hospital (during hospitalization or outpatient visit); Ablation procedure in hospital; One-month follow-up visit. Baseline Data The Following information will be collected for each enrolled patient at the initial visit: Patient demographics (date of birth, gender, ethnic origin, height/weight) Previous therapies or interventions to treat AF, including cardioversion and ablation AF characteristics (paroxysmal or persistent) Cardiovascular risk factors, concomitant cardiovascular diseases and other diseases/conditions Concomitant medications Stroke and bleeding risk profiles based on CHA2DS2 (Congestive heart failure, Hypertension, Age, Diabetes Mellitus, Stroke) - VASc27 (Vascular disease, Age, Sex) score, and HAS (Hypertension, Abnormal renal and liver function, Stroke) - BLED28 (Bleeding, Labile International Normalized Ratio, Elderly, Drugs or alcohol) score. Data on the AF-related diagnostic assessment, including electrocardiographic assessment, blood biochemistry, echocardiography and other diagnostic procedures, if performed as part of routine care Inform consent signature Ablation procedure Type of Ablation procedure Activated Clotting Time (ACT) Adverse Event (AE)/Serious Adverse Event (SAE) Major complication events Follow-Up Data Follow-up data at 1 month will be collected for all patients. The following information will be obtained by phone or during a visit to the center for each enrolled patient: Any bleedings event described in the study protocol; Major complications described in the study protocol; Adherence to Non-VKA Oral Anticoagulant (NOACs) therapy, Concomitant medications; Concomitant procedures; AE/SAE.

Official Title
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Italian Registry In the Setting of AF Ablation With Rivaroxaban

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Rivaroxaban
* Procedure: Catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suitable for anticoagulant therapy and catheter ablation; Scheduled for Non Valvular Atrial Fibrillation (NVAF) catheter ablation; Paroxysmal or persistent NVAF; Patient naïve or in therapy with Rivaroxaban; Written informed consent. Exclusion Criteria: Patients who do not agree with study inclusion; Impossible to Non-VKA Oral Anticoagulant (NOAC); Moderate to severe hepatic impairment; Pregnancy or lactation; Creatinine Clearance (CrCl) < 15 ml/min.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nonvalvular atrial fibrillation patients (NVAF)<br>Eligible patients comprise men and women aged 18 years or older with nonvalvular atrial fibrillation diagnosis undergoing ablation procedure. | Drug: Rivaroxaban<br>* Rivaroxaban therapy for at least 4 weeks.<br>Procedure: Catheter ablation<br>* Radiofrequency catheter ablation or cryoballoon ablation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of thromboembolic and bleeding events. | Thromboembolic events: Ischemic stroke; Vascular death. Major bleeding events: Fatal bleeding; Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; Bleeding causing a fall in hemoglobin level of 20 g L-1 or more, or leading to transfusion of two or more units of whole blood or red cells. Non-major clinically relevant bleeding events: overt bleeding not meeting the criteria for major bleeding but associated with medical intervention. | 30 ± 5 days after the catheter ablation procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness endpoints | The secondary endpoint is the incidence of any of the below listed events within the first 30 days after the catheter ablation procedure: Stroke; Transient ischemic attack (TIA); Myocardial infarction (MI); Venous Thromboembolism (VTE). | 30 days after the catheter ablation procedure. | 
| Ablation procedure endpoints | The secondary endpoint is the incidence of any of the below listed events within the first 30 days after the catheter ablation procedure: Death; Tamponade; Total femoral pseudoaneurysm; Total artero-venous fistulae. | 30 days after the catheter ablation procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter ablation, Rivaroxaban, Real-world clinical practice, Italian registry, Non-valvular Atrial Fibrillation