Italian Registry In the Setting of AF Ablation With Rivaroxaban
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Incidence of thromboembolic and bleeding events.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Nonvalvular atrial fibrillation patients (NVAF)
Eligible patients comprise men and women aged 18 years or older with nonvalvular atrial fibrillation diagnosis undergoing ablation procedure.
干预措施: Rivaroxaban (Drug)
Nonvalvular atrial fibrillation patients (NVAF)
Eligible patients comprise men and women aged 18 years or older with nonvalvular atrial fibrillation diagnosis undergoing ablation procedure.
干预措施: Catheter ablation (Procedure)
结局指标
主要结局
Incidence of thromboembolic and bleeding events.
时间窗: 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.
次要结局
- Ablation procedure endpoints(30 days after the catheter ablation procedure.)
- Effectiveness endpoints(30 days after the catheter ablation procedure.)
研究者
Dr Carlo Lavalle
Medical Director at the Department of Cardiovascular, Respiratory, Nephrological, Anesthesiological and Geriatric Sciences.
Azienda Policlinico Umberto I