NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation - Post Approval Registry
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 437
- 主要终点
- The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure.
研究概览
简要总结
The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).
详细描述
This registry is a prospective, multi-center, non-randomized post approval evaluation comprised of two (2) registry arms with independent hypotheses. The registry arms are defined as; Arm 1) physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year and Arm 2) physicians who perform less than 50 atrial fibrillation ablation procedures per year. Subjects with drug refractory recurrent symptomatic PAF will be considered for this post approval registry. This registry will be conducted at up to 40 centers in a minimum of 381 evaluable subjects. The devices are currently FDA approved for commercial distribution under PMA #P030031/S11.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Candidates for this registry must meet ALL of the following criteria:
- •Patients with drug refractory recurrent symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment and one AF episode documented within the one (1) year prior to enrollment. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
- •Failure of at least one AAD for AF (class I or III or AV nodal blocking agent such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic PAF, or intolerable side effects.
- •Age 18 years or older.
- •Able and willing to comply with all pre-, post- and follow-up testing and requirements.
- •Signed Patient Informed Consent Form.
排除标准
- •Candidates will be excluded from the registry if any of the following conditions apply:
- •Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- •AF episodes that last longer than 30 days and are terminated via cardioversion.
- •CABG procedure within the last six (6) months.
- •Awaiting cardiac transplantation or other cardiac surgery.
- •Documented left atrial thrombus on imaging (i.e., TEE, ICE, CT, or MRA).
- •History of a documented thromboembolic event within the past one (1) year.
- •Diagnosed atrial myxoma.
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this registry.
- •Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).
- •Acute illness or active systemic infection or sepsis.
- •Unstable angina.
- •Uncontrolled heart failure.
- •Myocardial infarction within the previous two (2) months.
- •History of blood clotting or bleeding abnormalities.
- •Contraindication to anticoagulation (i.e. heparin or warfarin).
- •Life expectancy less than 12 months.
- •Enrollment in an investigational study evaluating another device or drug.
- •Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
结局指标
主要结局
The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure.
时间窗: Seven days post ablation procedure
The 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, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular access complications, Pulmonary edema, Hospitalization (including initial and prolonged, excluding those hospitalizations solely due to pre-existing arrhythmia recurrence), Heart block. Pulmonary vein stenosis (defined as ≥70% diameter reduction) and atrio-esophageal fistula occurring more than 7 days post-procedure shall be deemed a Primary AE. The primary endpoint for the Post-Approval Registry is a comparison of the 7-day primary AE rate against a performance criterion of 16 %. The 16% performance criterion is based on literature data and discussion with the FDA per IDE G030236.
次要结局
- Percentage of Subjects Experienced Serious Adverse Events.(First study day to 5 year post-ablation)