NCT03626649已完成不适用
A Prospective Single Arm Clinical Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation
Medtronic Cardiac Rhythm and Heart Failure5 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2018年5月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Freedom from a composite of serious adverse events (SAE)
研究概览
简要总结
The objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use.
详细描述
- The DiamondTemp Ablation System is indicated for use in patients requiring cardiac electrophysiological mapping (stimulation and recording) and, when used in conjunction with a radiofrequency generator and irrigation pump, for cardiac ablation with monitoring of tissue temperature during ablation.
- In this study, the DiamondTemp Ablation System will be evaluated for the treatment of patients with atrial fibrillation.
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
- •Suitable candidate for intra-cardiac mapping and ablation for arrhythmias
- •History of recurrent symptomatic PAF with ≥2 episodes reported within the 365 days
- •(12) months prior to enrollment
- •At least 1 episode of AF documented by Holter monitor, rhythm strip, trans-telephonic monitor (TTM), or 12-lead ECG prior to enrollment
- •Refractory to at least one Class I-IV anti-arrhythmic drug (AAD)
- •Eighteen (18) years of age or above
排除标准
- •Previous left atrial ablation procedure
- •Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement
- •Known severe cerebrovascular disease or history of cerebrovascular event (< 1 month)
- •Subjects with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR)3 with a GFR ≤
- •Active gastrointestinal bleeding
- •Active infection or fever (>100.5 F/38 ◦C)
- •Cardiac surgery within the past two months.
- •Short life expectancy (<1 yr.) due to other illnesses, such as cancer or pulmonary, hepatic, or renal disease Significant anemia (hemoglobin < 8.0 mg/dL)
- •Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg within the last 30 days)
- •Documented anaphylaxis during previous exposure to angiographic contrast media
- •Uncontrolled congestive heart failure (NYHA1 Class III or IV)
- •Unstable angina or acute myocardial infarction within the past three months
- •Bleeding, clotting disorders, or known thrombosis
- •Severe Peripheral vascular disease
- •Uncontrolled diabetes
- •Heart valve replacement
- •Mitral clip (E-valve)
- •Women who are of childbearing potential who are currently pregnant or not willing to use contraception for the duration of the study
- •Active participation in another investigational protocol currently or the last 30 days
- •Unable or unwilling to take anti-coagulants
- •Unwilling or unable to comply with any protocol or follow up requirements
结局指标
主要结局
Freedom from a composite of serious adverse events (SAE)
时间窗: 30 days
Freedom from a composite of serious adverse events (SAE)
Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes
时间窗: 12 months
Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes
次要结局
- Freedom from a composite SAE(7 days)
- Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes(12 months)
- Rate of single procedure success(12 months)
研究者
研究点 (5)
Loading locations...
相似试验
招募中
不适用
An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial ArrhythmiaNCT06157437Hangzhou Dinova EP Technology Co., Ltd10
已完成
不适用
Evaluation of the Safety and Efficacy of the CardioPulseTM PuLsed fiEld Ablation SystEm in Patients With Paroxysmal Atrial Fibrillation (PLEASE-AF Study)Paroxysmal Atrial FibrillationNCT05114954Hangzhou Dinova EP Technology Co., Ltd158
Unknown
不适用
Safety & Performance of the Centauri System for Patients With Atrial FibrillationAtrial FibrillationNCT04652778Galaxy Medical, Inc.15
已完成
不适用
Clinical Investigation of the VytronUS Ablation System for Treatment of Paroxysmal Atrial FibrillationParoxysmal Atrial FibrillationNCT03639597VytronUS, Inc.53
已完成
不适用
Exploratory Clinical Study to Evaluate the Efficacy and Safety of Tixel C for the Treatment of Myoblast DysfunctioMeibomian gland dysfunctionJPRN-jRCTs032220286Yuichi Hori20