A Prospective Randomized Trial for the Comparison of Procedural Characteristics and Long-term Effects of Radiofrequency Ablation and Balloon Cryoablation in Elderly Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- atrial arrhythmia recurrence
研究概览
简要总结
This study compares the procedural characteristics and effectivity of radiofrequency ablation and cryoablation in patients with atrial fibrillation that are 75 years or older.
详细描述
Radiofrequency and cryoballon ablation have been shown to be comparable to each other in terms of safety and effectivity in patients with atrial fibrillation. However, elderly patients have been underrepresented in the previous studies. The number of older patients with atrial fibrillation is high and the number of who undergo an ablation procedure for atrial fibrillation increases steadily. This prospective randomized trial compares the effectivity (recurrency of atrial arrhythmias) and periprocedural characteristics of the two established ablation methods in patients who are 75 years or older.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recurrent symptomatic paroxysmal or persistent atrial fibrillation
- •At the day of their inclusion in the study the patients have to have completed the 75th year of life
排除标准
- •Presence of left atrial thrombus
- •Left atrial volume> 50 ml/m²
- •Renal failure (GFR≤ 30 ml/min)
- •Comorbidity with an expected survival of 12 months or less.
结局指标
主要结局
atrial arrhythmia recurrence
时间窗: 1 year
Number of Participants with recurrence of any atrial arrhythmia with a duration of 30 sec or longer 12 months after the ablative treatment
次要结局
- procedural duration(periprocedural)
- contrast medium dosis(periprocedural)
- vascular complications(1 year)
- Propofoldosis(periprocedural)
- groin complications(up to 3 months after dismission from the hospital)
- time to wake-up after propofol withdrawal(periprocedural)
- Neurological complications(1 year)
- duration of hospital staying [days](1 year)
研究者
Charalampos Kriatselis
Principal Investigator
Vivantes Netzwerk für Gesundheit GmbH