Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 7
- 主要终点
- Number of Subjects Achieved Acute Procedural Success
研究概览
简要总结
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
详细描述
The purpose of this study is to evaluate safety and acute performance of the THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode in the treatment of Paroxysmal Atrial Fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures.
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
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
- •Age 18 or older.
- •Signed the Patient Informed Consent Form (ICF).
- •Diagnosed with symptomatic PAF
- •Selected for catheter ablation through pulmonary vein isolation.
- •Able and willing to comply with all pre-, post-, and follow-up testing and requirements (e.g. patient not confined by a court ruling).
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.
- •Previously diagnosed with persistent, longstanding AF and/or continuous AF >7 days, or >48 hrs. terminated by cardioversion.
- •Documented Left Atrial thrombus on baseline/pre-procedure imaging.
- •Any carotid stenting or endarterectomy.
- •Left atrial (LA) size >50mm.
- •Left Ventricular ejection fraction (LVEF) <40%.
- •Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
- •History of blood clotting or bleeding abnormalities
- •Contraindication to anticoagulation
- •History of a documented thromboembolic event (including transient ischemic attack (TIA)) within the past 12 months.
- •Previous percutaneous coronary intervention (PCI) or myocardial Infarction (MI) within the past 2 months.
- •Coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (e.g. ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure.
- •Rheumatic Heart Disease
- •Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
- •Unstable angina.
- •Significant pulmonary disease (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other diseaseor malfunction of the lungs or respiratory system that produces chronic symptoms.
- •Acute illness, active systemic infection, or sepsis.
- •Presence of atrial myxoma, interatrial baffle or patch
- •Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
- •Presence of a condition that precludes vascular access.
- •Presence of implanted pacemaker or implantable cardioverter-defibrillator (ICD).
- •Presence of IVC filter
- •Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial.
- •Currently enrolled in an investigational study evaluating another device, biologic, or drug.
- •Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
- •Life expectancy or other disease processes likely to limit survival to less than 12 months.
- •Presenting contra-indication for the devices used in the study, as indicated in the respective instructions for use.
- •Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
- •Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion)
- •Presence of iron-containing metal fragments in the body
- •Unresolved pre-existing neurological deficit.
结局指标
主要结局
Number of Subjects Achieved Acute Procedural Success
时间窗: Day 1
Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge.
Incidence of Acute Safety
时间窗: 7 days post-procedure
Defined as the incidence of early-onset predefined primary adverse events within 7 days of the study procedure, including atrio-eophageal fistula, phrenic nerve paralysis , cardiac tamponade/perforation , pulmonary vein stenosis, death, stroke/CVA, major vascular access complication/bleeding , thromboembolism, myocardial infarction, transient ischemic attack. Device or procedure related death, pulmonary vein stenosis and atrio-esophageal fistula that occur beyond 7 days post- procedure were also be deemed primary AEs.
次要结局
未报告次要终点