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

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StatusRecruiting

Keywords

Abstract

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.

Description

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.

Dates

Last Verified:	05/31/2020
First Submitted:	03/17/2020
Estimated Enrollment Submitted:	03/17/2020
First Posted:	03/19/2020
Last Update Submitted:	06/03/2020
Last Update Posted:	06/04/2020
Actual Study Start Date:	05/14/2020
Estimated Primary Completion Date:	02/28/2022
Estimated Study Completion Date:	02/28/2022

Condition or disease

Atrial Fibrillation

Intervention/treatment

Drug: Nonvalvular atrial fibrillation patients (NVAF)

Procedure: Nonvalvular atrial fibrillation patients (NVAF)

Phase

Arm Groups

Arm	Intervention/treatment
Nonvalvular atrial fibrillation patients (NVAF) Eligible patients comprise men and women aged 18 years or older with nonvalvular atrial fibrillation diagnosis undergoing ablation procedure.	Drug: Nonvalvular atrial fibrillation patients (NVAF) Rivaroxaban therapy for at least 4 weeks.

Eligibility Criteria

Ages Eligible for Study	18 Years To 18 Years
Sexes Eligible for Study	All
Sampling method	Probability Sample
Accepts Healthy Volunteers	Yes
Criteria	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.

Outcome

Primary Outcome Measures

1. Incidence of thromboembolic and bleeding events. [30 ± 5 days after the catheter ablation procedure.]

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.

Secondary Outcome Measures

1. Effectiveness endpoints [30 days after the catheter ablation procedure.]

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).

2. Ablation procedure endpoints [30 days after the catheter ablation procedure.]

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.

Other Outcome Measures

1. Activated Clotting Time (ACT) [During the ablation procedure.]

ACT evaluation to assess procedural heparin dose requirement during the ablation procedure.

2. Study medication adherence [At baseline and after 30 days.]

The study medication adherence is evaluated counting pills from the blister at baseline and after 30 days.

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

Keywords

hemorrhage

stroke

atrial fibrillation

thrombosis

diabetes mellitus

heart failure

antifungal

anticoagulant