Advanced Cardiac Therapeutics DiamondTemp TempeRAture-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Nature and frequency of serious adverse events (SAE) and serious adverse device effects (SADE)
研究概览
简要总结
The primary objective of this study is to establish the safety and performance effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF).
详细描述
Study Title: Advanced Cardiac Therapeutics DiamondTemp TempeRAture-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial Fibrillation: TRAC-AF
Sponsor: Advanced Cardiac Therapeutics 2880 Lakeside Drive Suite 250 Santa Clara, CA 95054
Protocol No: DTAF-CZ01
Product: Cardiac Ablation Catheter and RF Generator/Pump System Investigational Device: DiamondTemp System (Inclusive of the DiamondTemp Ablation Catheter, DiamondTemp Catheter-to-RFG Cable, DiamondTemp GenConnect Cable, DiamondTemp RF Generator, DiamondTemp Irrigation Pump and DiamondTemp Irrigation Tubing)
PROTOCOL SUMMARY Advanced Cardiac Therapeutics DiamondTemp TempeRAture-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial Fibrillation: TRAC-AF
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
- •Study Inclusion Criteria
- •Subjects for this study must meet ALL of the following criteria:
- •Suitable candidate for intra-cardiac mapping and ablation for arrhythmias.
- •History of recurrent symptomatic PAF1 WITH ≥2 episodes reported within the 365 days (12) months prior to enrollment.
- •At least one 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
- •Competent and willing to provide written informed consent to participate in the study and agree to comply with the follow-up visits and evaluation.
排除标准
- •Candidates will be excluded from the study if any of the following conditions apply:
- •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 (within 1 month)
- •Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR)3 with a GFR ≤
- •This is calculated as follows for males:
- •GFR = (140 - age) x weight x .85 (for females) PCr x 72 where age is specified in years, weight in kg, and PCr is Serum Creatinine in mg/dL Female GFR is reduced by 15% of the above calculated value for males.
- •Active gastrointestinal bleeding
- •Active infection or fever (> 100.5 F/38 C)
- •Cardiac surgery within the past two months
- •Short life expectancy (< 1yr) 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 press. > 240 mm Hg within the last 30 days)
- •Documented anaphylaxis during previous exposure to angiographic contrast media
- •Uncontrolled congestive heart failure (NYHA 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
- •Rheumatic heart disease
- •Heart valve replacement
- •Mitral clip (Evalve)
- •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
Nature and frequency of serious adverse events (SAE) and serious adverse device effects (SADE)
时间窗: Seven days
The safety of the DiamondTemp System will be assessed by evaluating the nature and frequency of serious adverse events (SAE) and serious adverse device effects (SADE) during the time of the ablation procedure and within 7 days afterwards.
Electrical Isolation of treated Pulmonary Vein from Left Atrium
时间窗: Seven days
The effectiveness of the DiamondTemp System will be evaluated post-ablation with demonstration of acute procedural success defined as isolation of clinically relevant pulmonary veins by demonstration of block or isolation of signals confirmed after delivery of the ablation treatment. Depending on EP lab protocol, one method will be chosen.
次要结局
- Nature and frequency of serious adverse events (SAE) and serious adverse device effects (SADE) up to a year after treatment(During 12 months after the treatment)