NCT02257060已完成1 期
Evaluation of a Multi-Electrode Linear Type Ablation Catheter for Endocardial Ablation of Patients With Right Atrial Flutter
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Safety
研究概览
简要总结
The Linear II study is a prospective, single center, non-randomized, interventional feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear Type Ablation Catheter and the performance of the product when used for the treatment of symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •At least one symptomatic episode of typical CTI dependent right atrial flutter documented by 12 lead ECG, Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device.
- •Age 18 years or older.
排除标准
- •Previous typical CTI dependent right atrial flutter ablation
- •Uncontrolled heart failure or NYHA function class IV
- •MI within the past 2 months
- •Any cardiac surgery (i.e. CABG) within the past 2 months
- •Subjects that have ever undergone valvular cardiac surgical procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
- •Awaiting cardiac transplantation or other cardiac surgery within the next 6 months
- •Documented thromboembolic event (including TIA) within the past 12 months
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- •Active illness or active systemic infection or sepsis
- •Unstable angina
- •History of blood clotting or bleeding abnormalities
- •Contraindication to anticoagulation (eg, heparin or warfarin)
- •Life expectancy less than 6 months
- •Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
- •Presence of a condition that precludes vascular access
- •Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation
- •Currently enrolled in another device, biologics, or drug study
- •Contraindication for use of the investigational catheter, as indicated in the respective Instructions For Use
结局指标
主要结局
Safety
时间窗: 7 Days
Incidence of early onset (within 7 days of ablation procedure) primary AEs
Acute performance
时间窗: This outcome measure will be assessed during the procedure but after 30 minutes (or more) of the initial ablation
Acute procedural success as confirmed complete bidirectional conduction block across the CTI (assess ≥30 min following last RF application)
次要结局
- Safety(Until one-month follow-up)
- Acute Efficacy(Within 30 Days)
- Procedural data(During Procedure)
研究者
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