Prospective Safety Assessment of the THERMOCOOL® SMARTTOUCH® SF Family of Contact Force Sensing Catheters for the Radiofrequency Ablation Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 165
- 主要终点
- Percentage of Participants With Early Onset Primary Adverse Events
研究概览
简要总结
This is a prospective safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation (SMART-SF).
详细描述
The purpose of this study is to demonstrate the safety of the study device in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures.
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
- •Symptomatic paroxysmal atrial fibrillation (AF) who have had at least one AF episode electrocardiographically documented within one (1) year prior to enrollment and a physician's note indicating recurrent, self-terminating AF. Electrocardiographic documentation may include, but is not limited to, electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip
- •Failed at least one antiarrhythmic drug (AAD) (class I or III, or atrioventricular (AV) nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerable to the AAD
- •Age 18 years or older
排除标准
- •Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- •Previous surgical or catheter ablation for atrial fibrillation
- •Amiodarone at any time during the past 3 months
- •Any percutaneous coronary intervention (PCI), cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) within the past 2 months
- •Any carotid stenting or endarterectomy
- •Coronary artery bypass graft (CABG) surgery within the past 6 months
- •AF episodes lasting >7 days
- •Documented left atrial (LA) thrombus on imaging
- •LA size >50 mm
- •Left ventricular ejection fraction (LVEF) < 40%
- •Contraindication to anticoagulation (heparin or warfarin)
- •History of blood clotting or bleeding abnormalities
- •MI within the past 2 months
- •Documented thromboembolic event (including transient ischemic attack (TIA)) within the past 12 months
- •Rheumatic Heart Disease
- •Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV
- •Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
- •Unstable angina
- •Acute illness or active systemic infection or sepsis
- •Diagnosed atrial myxoma
- •Presence of implanted implantable cardioverter defibrillator (ICD)
- •Significant pulmonary disease, (eg, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- •Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
- •Enrollment in an investigational study evaluating another device, biologic, or drug
- •Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter
- •Presence of a condition that precludes vascular access
- •Life expectancy or other disease processes likely to limit survival to less than 6 months
研究组 & 干预措施
Treatment Group
Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
干预措施: THERMOCOOL® SMARTTOUCH® (RF ablation treatment) (Device)
结局指标
主要结局
Percentage of Participants With Early Onset Primary Adverse Events
时间窗: Seven days post ablation procedure
Early onset is defined as within 7 days of the atrial fibrillation (AF) ablation procedure. Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade / Perforation, Pneumothorax, Major Vascular Access Complications / Bleeding, Pulmonary edema (Respiratory Insufficiency), and Heart block.
次要结局
- Percentage of Participants With Non-Primary Serious Adverse Events (SAEs)(Up to 30 days post Procedure)
- Percentage of Participants With Acute Success(End of procedure)
- Effectiveness Endpoint: Freedom From Documented Atrial Fibrillation (AF)/Atrial Tachycardia (AT)/Atrial Flutter (AFL)(12 months)