Safety and Efficacy of Cryoballoon Pulmonary Vein Isolation : a Single Center Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,003
- 试验地点
- 1
- 主要终点
- Long term efficacy of cryoballoon ablation for atrial fibrillation (AF)
研究概览
简要总结
The aim of this study was to assess the long-term success rates of pulmonary vein isolation using first and second generation cryoballoons in patients with paroxysmal and persistent atrial fibrillation.
详细描述
The success of ablation is determined by the absence of recurrence of atrial fibrillation in the short term beyond 3 months, medium and long term on regular clinical follow-up and ECG holters. The patient cohort followed since 2007 allows a very long-term follow-up of patients who have benefited from atrial fibrillation cryoablation.
Isolation of the pulmonary veins by cryoballoon (IVP) has emerged as an alternative to radiofrequency in the treatment of drug resistant atrial fibrillation (AF). (1) The potential benefits of cryoablation include shorter procedure times, decreased fluoroscopy time, shorter hospital duration, a different rate and type of complications compared to radio frequency offers potential benefits, including Including shorter procedure times, a decrease in the length of hospital stay 1 and a reduction in fluoroscopic time. (2) Effectiveness on a one year follow-up in cryoablation for AF is comparable to that of radiofrequency ablation in a prospective, randomized study with a lower major complication rate (3,4). The number of subjects is limited and most retrospective studies on cryoablation have a limited number of patients or an average follow-up not exceeding one year.
Study of the data and results of the procedures of ablation of AF by cryoablation and long-term follow-up of the patients of the CHU of Grenoble.
Regular monocentric cohort study based on collected data To identify the success rate of cryoablation ablation in paroxysmal and persistent AF
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an indication for ablation of atrial fibrillation at the CHU of Grenoble since the use of this technique (November 2007) until November 2016:
- •Paroxysmal atrial fibrillation resistant to antiarrhythmic treatment.
- •Persistent atrial fibrillation.
- •Patients ≥18 years
- •Patients with discernment who signed consent for information on the ablation procedure before surgery.
排除标准
- •patient less than 18 years old
- •patient who refused to sign informed consent for the procedure of ablation
结局指标
主要结局
Long term efficacy of cryoballoon ablation for atrial fibrillation (AF)
时间窗: in a 8-year follow-up period
Absence of recurrence (recurrence was defined as symptomatic or documented arrhythmia episode of\>30 seconds excluding a 3-month blanking period)
次要结局
- Post procedure morbidities(in a 8-year follow-up period)
- Continuation of medical treatment post ablation(in a 1200-day follow-up period)
- Cryoballoon 1 versus cryoballoon 2(in a 1200-day follow-up period)
- Clinical characteristics and predictive factors for success / complications(in a 8-year follow-up period)