Clinical Evaluation of Therapy™ Cool Flex™ Irrigated Ablation System for the Treatment of Typical Atrial Flutter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 24
- 主要终点
- Primary Efficacy
研究概览
简要总结
To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.
详细描述
This will be a prospective, multi-center and non-randomized study. All treated patients will receive ablation therapy for typical atrial flutter using the TherapyTM Cool FlexTM Irrigated Ablation System. Historical data from combined published (PMA P060019 Cool Path) and reported (IDE G090109 Cool Path Duo) Atrial Flutter studies will be used to determine performance goals for study endpoints.
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
- •A signed written Informed Consent
- •Presence of typical atrial flutter (cavo-tricuspid isthmus dependent)
- •If subjects are receiving anti-arrhythmic drug therapy (Class I or Class III AAD) for an arrhythmia other than typical atrial flutter, then the subject needs to be controlled on their medication for at least 3 months. If the subject had typical atrial flutter before starting the AAD(s) (Class I or Class III) and then subsequently had another arrhythmia (i.e. atrial fibrillation), then the 3 month AAD criteria will not apply
- •One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry strip, or transtelephonic monitor within the past 6 months
- •In good physical health
- •18 years of age or older
- •Agree to comply with follow-up visits and evaluation
排除标准
- •Prior typical atrial flutter ablation treatment
- •Pregnancy
- •Atypical flutter or scar flutter (non isthmus dependent)
- •Significant coronary heart disease or heart failure; that is unstable angina pectoris and/or uncontrolled congestive heart failure (NYHA Class III or IV) at the time of enrollment
- •A recent myocardial infarction within 3 months of the intended procedure date
- •Permanent coronary sinus pacing lead
- •Clinically significant Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve
- •Evidence of intra-cardiac thrombus or a history of clotting disorders
- •Participation in another investigational study
- •Cardiac surgery within 1 month prior to the intended procedure date
- •Allergy or contraindication to Heparin
研究组 & 干预措施
Treatment Arm
Radio-frequency cardiac ablation for treatment of isthmus-dependant atrial flutter using the Therapy™ Cool Flex™ Irrigated Ablation System
干预措施: Therapy™ Cool Flex™ Irrigated Ablation System (Device)
结局指标
主要结局
Primary Efficacy
时间窗: 30 minutes
Primary efficacy or acute success is defined as achievement of bi-directional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.
Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure
时间窗: 7 days
Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.
次要结局
- Secondary Efficacy(3 months)