Cabana Image Analysis Lab

Cabana 图像分析实验室

• 批准号: 8420513
• 负责人: RICHARD A ROBB
• 金额: $ 24.92万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-02-01 至 2015-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8420513
• 关键词: 4D Imaging; Ablation; Aftercare; Age; Age-Years; Algorithms; Anti-Arrhythmia Agents; Arrhythmia; Atrial Fibrillation; Atrial Function; Caliber; Cardiac Surgery procedures; Cardiac ablation; Cardiovascular system; Catheters; Characteristics; Chest; Cicatrix; Clinical Trials; Communication; Computer software; Data Coordinating Center; Drug Controls; EFRAC; Eligibility Determination; Esophageal injury; Esophagus; Failure; Functional disorder; Goals; Health Care Costs; Health Policy; Healthcare; Heart Arrest; Heart Atrium; Heart Diseases; Hemorrhage; Holter Electrocardiography; Image; Image Analysis; Incidence; Investigation; Left; Left atrial structure; Link; Living Costs; Magnetic Resonance Imaging; Measurement; Measures; Medical; Methods; Monitor; Morbidity - disease rate; Morphology; Myocardial; Operative Surgical Procedures; Outcome; Pacemakers; Patients; Performance; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacotherapy; Phase; Prevalence; Process; Protocols documentation; Public Health; Pulmonary veins; Quality of life; Radiofrequency Catheter Ablation; Randomized; Recurrence; Relative (related person); Reporting; Research Personnel; Risk; Risk Factors; Role; Scanning; Shapes; Sinus; Stenosis; Stroke; Structure; Symptoms; System; Techniques; Testing; Three-Dimensional Image; Tissues; Validation; Variant; aging population; arm; base; cost; cost effectiveness; evidence base; graphical user interface; improved; insight; interest; minimally invasive; modifiable risk; mortality; response; treatment effect; treatment strategy

DESCRIPTION (provided by applicant): The investigator-initiated, Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial will test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) is superior to current state-of-the-art pharmacologic therapy with either rate control or rhythm control drugs for reducing total mortality (primary endpoint) and decreasing the composite endpoint of total mortality, disabling stroke, serious bleeding and cardiac arrest (secondary endpoint) in patients with untreated or incompletely treated AF warranting therapy. Additional secondary endpoints will include AF recurrence and quality of life and cost effectiveness. The need for this trial arises out of 1) the rapidly increasing number of patients >60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy in multiple recent trials to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radiofrequency catheter ablation for AF without appropriate evidence-based validation, and 4) the resulting impact of AF on national health care costs. This 140-center mortality study will randomize 3000 patients over 3 years to a strategy of catheter ablation (n=1500) vs. state-of-the-art rate or rhythm control drug therapy (n=1500). Each patient will have 1) characteristics similar to AFFIRM patients (age >65, or <65 with >1 risk factor for stroke, 2) documented AF warranting treatment, and 3) eligibility for both catheter ablation and >2 anti-arrhythmic or >3 rate control drugs. Patients will be followed every 6 months for >2 yrs (median 3.5 yrs) and will undergo repeat trans-telephonic monitoring, Holter monitoring, and CT/MR studies to assess the impact of treatment. The primary and secondary endpoints will be examined in pts with paroxysmal, persistent, or permanent AF, without regard to age or underlying heart disease. With an anticipated 3.5 year mortality rate of >12% in drug treated patients, 1500 patients in each treatment arm will provide 90% power for detecting a 30% relative reduction in overall mortality and >90% power for detecting a 25% reduction in the composite secondary endpoint. The CABANA trial will disclose the role of medical and ablative therapies for an ever-escalating national healthcare dilemma, ascertain the cost and influence of therapy on quality of life, establish the impact of therapy on atrial morphology and function, and will help determine if AF is a modifiable risk factor for cardiovascular mortality. CABANA will be a landmark trial that will guide therapy and shape health care policy in the AF arena for years to come.

描述（由申请人提供）： 研究人员发射的导管消融与抗心律失常药物治疗对心房颤动（Cabana）试验将检验以下假设：经皮静处静室导管消融的治疗策略是消除目前的基本药物控制或Rhyth Practoration Contranity Contranity Contration Carterritation或Rhyth Pressality Contration Cartery（AF），供应了任何率（Rhy）的速率（Ryth）的总和（Ryth）的总和（RYTH CRY CRY（RYTH）的总和（Ryth）的总和（RYTH）的总和（RYTH）均优质并降低了未治疗或不完全治疗的AF保证治疗患者的总死亡率，残疾中风，严重出血和心脏骤停（次要终点）的综合终点。其他次要终点将包括AF复发和生活质量和成本效益。对这项试验的需求来自1）伴随着症状和发病率的60岁以上的患者数量迅速增加，2）在最近的多项试验中，抗心律失常药物治疗失败，以维持鼻窦节奏的死亡率并降低死亡率，3）迅速增加了对AF的适用于AF的应用程序，而无需进行基于验证的验证，而无需进行适当的验证，而对4）进行了验证，以及4）。 这项140个中心的死亡率研究将在3年内随机将3000名患者随机，以与最先进的率或节律控制药物治疗（n = 1500）相比导管消融策略（n = 1500）。每个患者的特征将具有1）类似于肯定患者的特征（年龄> 65岁，<65岁，中风的危险因素> 1），2）记录的AF保证治疗； 3）有资格进行导管消融和> 2抗心律失常或> 3速率控制药物。患者每6个月进行> 2年（中位3.5岁）进行一次，并将进行反复跨性别的监测，Holter监测和CT/MR研究以评估治疗的影响。主要和次要终点将在具有阵发性，持久性或永久性AF的PT中检查，而无需考虑年龄或潜在的心脏病。 预期的3.5岁死亡率在药物治疗的患者中> 12％，每个治疗组中有1500名患者将提供90％的功率，以检测总体死亡率相对降低30％，并且> 90％的功率> 90％，以检测复合次级终点的25％降低。 Cabana试验将披露医学和消融疗法在不断升级的国家医疗保健困境中的作用，确定治疗对生活质量的成本和影响，确定治疗对心房形态和功能的影响，并将有助于确定AF是否是可修改的危险因素对心血管死亡的危险因素。 Cabana将是一项具有里程碑意义的试验，将在未来几年内指导治疗并塑造AF竞技场的医疗保健政策。