Atrial Flutter Ablation in a Real World Population: A Multicenter Italian Registry (The LEONARDO Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Percentage of Subjects With Complete Bidirectional Conduction Block
研究概览
简要总结
The "LEONARDO" study is a non-randomized, multicenter, prospective study in which consecutive patients indicated for Atrial Flutter isthmus-dependent (AFL) ablation will be enrolled. Patients can be treated with any market released catheter for ablation. The decision to perform the ablation of AFL will be made based on clinical evaluation of the investigators according to their clinical practice. The study does not require specific surgical techniques. Patient time commitment for the study is approximately 12 months.The study has been designed to describe the italian clinical practice in relation to the approach of AFL ablation. In particular, the investigators will describe the methods for the validation of ablation success, the techniques adopted, and the patient management approaches in the participating centers.
详细描述
Catheter ablation of Atrial Flutter has become an accepted alternative to pharmacologic therapy.The current guidelines recommend the catheter ablation at the first episode of AFL (Class IIa) or in any case of recurrent episodes of AFL (Class I). Recent studies have already demonstrated a high degree of procedural efficacy (higher than 90%). However, there are still two main areas of investigation. First, what is the best method to obtain an effective lesion. Second, what is the most reliable method to validate the procedure success.The present study is aimed at investigating these aspects in the current Italian clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing ablation of atrial flutter isthmus-dependent
- •Patient able to sign an authorization to use and disclose health information or an Informed Consent.
- •Patient available to attend scheduled follow-up visits at the center for at least 12 months
排除标准
- •Patient is participating in another clinical study that may have an impact on the study endpoints
结局指标
主要结局
Percentage of Subjects With Complete Bidirectional Conduction Block
时间窗: Time Frame: within 30 minutes after ablation procedure
Acute success is defined as the confirmation of complete bidirectional conduction block across the cavo-tricuspid isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.
次要结局
- Recurrence of symptoms of AFL, measured as the proportion of patients reporting symptoms during follow-up(12 months)
- Lesion's validation criteria(an average of 12 months following the ablation procedure)
- Ablation procedure time(intraoperative)
- Recurrence of AFL, measured as the proportion of patients with an episode longer than 30s documented at 24h Holter ECG recording during follow-up(12 months)
- Adverse Events during Follow up(12 months)
- Acute adverse events(intraoperative)
研究者
Giampiero Maglia
Head of Electrophysiology and Cardiac Pacing
Azienda Ospedaliera Pugliese Ciaccio