Navistar Thermocool Evaluation of the Catheter With the Stockert 70 Radiofrequency Generator for Endocardial Ablation in Patients With Typical Atrial Flutter
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 46
- 主要终点
- Percentage of Subjects With Complete Bidirectional Conduction Block.
研究概览
简要总结
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).
详细描述
This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. The device is currently FDA approved for commercial distribution. Subjects with symptomatic typical atrial flutter will be considered for the condition of approval study. This study will be conducted at up to 30 centers in a minimum of 221 evaluable subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Two symptomatic episodes of typical atrial flutter (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFL occurring while receiving anti-arrhythmic drug (AAD) therapy for non-AFL tachyarrhythmia, including atrial fibrillation.
- •At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device within 6 months prior to enrollment.
- •18 years of age or older
- •Informed consent
排除标准
- •Intracardiac thrombus
- •Uncontrolled heart failure, or New York Heart Association (NYHA) class III or IV heart failure
- •Women who are pregnant
- •Cardiac surgery (ventriculotomy or atriotomy) within the past two months
- •Intra-atrial thrombus, tumor, or other abnormality that precludes catheter introduction and placement
- •Unstable angina or acute myocardial infarction within 3 months
- •Awaiting cardiac transplantation
- •Heart disease in which corrective surgery is anticipated within 6 months
- •Presence of condition that precludes appropriate vascular access
- •Enrolled in any investigational device exemption (IDE) investigating study for a device or drug
- •High risk for non-compliance with the protocol (e.g., inaccessible for follow-up by the investigator or patient's physician)
- •Radio frequency (RF) ablation for typical atrial flutter within the past 2 months
结局指标
主要结局
Percentage of Subjects With Complete Bidirectional Conduction Block.
时间窗: During the procedure
Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.
Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure.
时间窗: 7 Days
The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study. A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death.
次要结局
未报告次要终点