Investigational New Drug Application/ Investigational Device Exemption Information
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 14
- 主要终点
- Number of Patients With Persistent Atrial Fibrillation (AF) After a Mean Follow-up of 15±7 Months: Comparison Between IAS and RAA Pacing in the Study Group
研究概览
简要总结
This study is a long-term, prospective, and controlled evaluation of the incidence of persistent atrial fibrillation (AF) in patients with severe intra-right atrial conduction delay paced with preventive algorithms at the interatrial septum (IAS) versus right atrial appendage (RAA).
详细描述
The EPASS is a multicenter, prospective, randomized, and controlled study.
Prior to entering the study, the patient should be informed and provide a written consent. In addition, the patient should meet all selection criteria. The Investigator has to check that all selection criteria are satisfied. Then the patient undergoes pacemaker implantation, receiving a pacemaker model T70 or Selection 9000 (or later version).
Patients eligible for the study are enrolled and submitted to the evaluation of intra-light atrial conduction delay before device implantation. Besides, they are assigned to the group with severe RA conduction delay or with normal conduction delay. The randomization of the pacing site for both groups depends on the value of right atrial conduction delay, together with the associated diseases of the patients, sex and age. After implantation, a stabilization phase of 3-5 weeks is required to stabilize the leads: during this period the physician can optimize the device parameters. Neither the data regarding AF episodes nor cardioversion are collected.
At the end of the stabilization phase the patient undergoes the 1st study follow-up and starts the monitoring period lasting 2 years. Regular follow-ups and data collection are scheduled every 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Symptomatic sinus node dysfunction
- •More than 18 years old
- •Signed informed consent
排除标准
- •Less than 18 years old
- •Pregnancy
- •Anamnestic transient ischemic attack (TIA) or stroke
- •Neoplastic or any other severe disease reducing life expectancy
- •Heart surgery in the last 3 months
- •Left atrial diameter > 55mm, determined in the parasternal long-axis view (during either sinus rhythm or atrial fibrillation)
- •Participation in other studies
结局指标
主要结局
Number of Patients With Persistent Atrial Fibrillation (AF) After a Mean Follow-up of 15±7 Months: Comparison Between IAS and RAA Pacing in the Study Group
时间窗: 1 year
Persistent Atrial Fibrillation (AF) incidence
次要结局
- Number of Patients With Permanent Atrial Fibrillation (AF)(January 2009)
- Number of Cardioversion: Comparison Between All Groups(January 2009)
- Number of Persistent Atrial Fibrillation (AF) Episodes: Comparison Between All Groups(January 2009)
- Symptom Scale Questionnaire: Comparison Between All Groups(January 2009)
- Heart Failure: Comparison Between All Groups(January 2009)
- Number of Episodes/Day(January 2009)
- AF Burden(January 2009)
- Time to First Persistent Episode of Atrial Fibrillation (AF)(January 2009)
- Ventricular Pacing Percentage(January 2009)