Implantable Monitor-Guided Anticoagulation for Non-Permanent Atrial Fibrillation

植入式监护仪引导抗凝治疗非永久性心房颤动

• 批准号: 8519528
• 负责人: ROD S PASSMAN
• 金额: $ 20.31万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8519528
• 关键词: Ablation; Address; Adverse event; Affect; Anticoagulants; Anticoagulation; Arrhythmia; Atrial Fibrillation; Cardiac; Cardiovascular system; Cessation of life; Chronic; Clinical Trials; Data; Devices; Disease; Dose; Enrollment; Event; Gastrointestinal Hemorrhage; Goals; Health; Health Personnel; Healthcare Systems; Heart failure; Hemorrhage; Home environment; Hospitalization; Hour; Incidence; Individual; Intervention; Intracranial Hemorrhages; Lead; Life; Methods; Minor; Modality; Monitor; Operative Surgical Procedures; Oral; Patients; Perception; Pharmaceutical Preparations; Pharmacology; Pharmacotherapy; Pilot Projects; Population; Public Health; Quality of life; Questionnaires; Recurrence; Risk; Risk Factors; SF-36; Sample Size; Sinus; Stroke; Stroke prevention; Technology; Thrombin; Thrombus; Time; Withdrawal; abstracting; base; cohort; compliance behavior; cost; data exchange; heart rhythm; improved; inhibitor/antagonist; insight; mortality; pill; premature; prevent; prospective; randomized trial; standard of care; subcutaneous; trial comparing

DESCRIPTION (provided by applicant): Atrial fibrillation (AF) is the most common sustained abnormal rhythm of the heart, affects an estimated 2.5 to 5 million individuals in the US, and can lead to stroke, heart failure, and premature death. For those with AF and other stroke risk factors, chronic anticoagulation is recommended to prevent intracardiac thrombus formation and stroke even if the AF is infrequent or short-lived. This standard of care is based partly on our inability to rapidly recognize and respond to AF recurrences which can often be brief and asymptomatic, but exposes the patient to the risk of anticoagulant-induced hemorrhage even during prolonged periods of sinus rhythm where the risk of stroke is presumably low. Recent advances in device technology and drug therapy, however, have the potential to change the way we manage AF. The use of a small leadless subcutaneous implantable cardiac monitor with remote data transmission capabilities (Reveal XT", Medtronic Inc.) provides the ability to remotely and continuously evaluate a patient for AF recurrences, even episodes that are brief and asymptomatic. In addition, the release of a unique oral thrombin inhibitor approved for use in non-valvular AF (Dabigatran [Pradaxa], Boehringer Ingelheim Inc.) allows for rapid onset anticoagulation within minutes to hours of a single oral dose. Together, these advances allow for continuous AF monitoring with targeted anticoagulation only around the time of an AF episode, thereby reducing the risk of drug-induced hemorrhage while still protecting against stroke. The aim of this pilot study is to assess the feasibility of intermittent anticoagulation wih dabigatran guided by continuous AF monitoring with Reveal XT" and remote data transmission to a healthcare provider. The study will enroll 75 AF patients from three centers with 1 or 2 other risk factors for stroke who have demonstrated persistent sinus rhythm following a rhythm control intervention which may include medications, ablation, or surgery. This pilot study will provide logistical insights, demonstrate feasibility, and generate required data for sample-size estimates for an anticipated large scale clinical trial comparing chronic anticoagulation with Reveal XT"-guided intermittent anticoagulation with dabigatran. This treatment modality can be anticipated to substantially reduce the exposure time to anticoagulation therapy, thereby reducing the risk of hemorrhage without increasing the risk of stroke. From a public health perspective, such a paradigm shift would reduce the cost of long-term anticoagulation, the impact of anticoagulant-related hemorrhage including the devastating consequences of intracranial hemorrhage, and improve quality of life in a portion of the millions of patients who already have AF and the 16 million expected to have the disease by the year 2050. If proven superior to current treatment methods this approach may improve a critical aspect of AF management and pave the way, along with advances in technology, for patient- directed in-home monitoring and treatment.

描述（由申请人提供）： 心房颤动（AF）是心脏最常见的持续异常节奏，影响了美国的2.5至500万个人，并可能导致中风，心力衰竭和过早死亡。对于患有AF和其他中风危险因素的人，建议使用慢性抗凝治疗，以防止心脏内血栓形成和中风，即使AF很少或短期寿命。该护理标准部分基于我们无法快速识别和应对通常是短暂和无症状的AF复发，但即使在长时间的窦性节奏时期，中风的风险大概很低，也使患者面临抗凝剂引起的出血的风险。但是，设备技术和药物治疗的最新进展有可能改变我们管理AF的方式。使用具有远程数据传输功能的少量无铅皮下可植入的心脏监护仪（显示XT”，Medtronic Inc.）提供了远程，连续评估患者的AF复发的能力Ingelheim Inc.允许在单个口服剂量的几分钟内快速发作抗凝，这些进步只能在AF发作时进行针对性的AF监测，从而降低药物诱导的出血性研究，同时降低了该试验的目标，从而降低了药物诱导的抗气性。通过显示XT和远程数据传输到医疗保健提供者的监视。该研究将招募来自三个中心的75名AF患者，其中1或2个 节奏控制干预后表现出持续的窦性心的中风的危险因素，其中可能包括药物，消融或手术。这项试点研究将提供后勤见解，证明可行性，并为一项预期的大规模临床试验生成所需的数据，以比较慢性抗凝作用，并揭示XT“指导性的间歇性抗凝与dabigatran。健康的角度看，这种范式的转变将降低长期抗凝作用的成本，与抗凝剂相关的出血的影响，包括颅内出血的毁灭性后果，以及改善已经在2050年的AF和1600万疾病的一部分患者中的一部分患者中的一部分，可以在2050年之前进行这种疾病。技术进步，用于患者的家庭监测和治疗。