Hybrid AF -- A Prospective Registry
Hybrid Procedure for the Treatment of Long Standing Persistent Atrial Fibrillation - A Prospective Registry
Atrial Fibrillation (AF) is a form of rapid irregular heart rhythm that starts in the upper chambers of the heart (called atria) and is often associated with many health problems. It can cause stroke, palpitations and heart failure. The management of long standing (chronic) AF may require additional medications and blood thinners, potentially for life. It may also require procedures where the heart is shocked with an electrical current to restore normal rhythm. Some patients require a procedure called radiofrequency ablation to address the arrhythmia.
The purpose of this registry is to collect information on patients undergoing this combination of procedures into a database, and to then use this information for scientific study to improve the treatment of atrial fibrillation.
研究概览
研究类型
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Documented effectiveness failure of at least one Vaughan-Williams Class III AAD
- Persistent AF as defined by the HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation
- Absence of significant structural heart disease as demonstrated by a transthoracic echocardiogram (TTE) of all four chambers of the heart, computed tomography (CT) scan or magnetic resonance imaging (MRI) scan within 6 months prior to enrollment
- Absence of left atrial thrombus as documented by an imaging study (e.g., TTE, transesophageal echocardiogram (TEE), thoracic CT scan, MRI, or left atrial angiography) within 30 days prior to procedure
Exclusion Criteria:
- History of longstanding persistent AF for more than 3 years
- Documented left atrial size of 60 mm or more
- Documented left ventricular ejection fraction (LVEF) less than 40%
- History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment
- Significant underlying structural heart disease requiring surgical or procedural intervention within the last six months of initial procedure
- Known contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy
- Other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis, etc.)
- Pregnancy, planned pregnancy (females of childbearing potential must have a negative pregnancy test prior to enrollment and agree not to become pregnant during the trial) or breastfeeding;
- Concomitant procedure planned
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
Atrial Fibrillation
Patients with Atrial Fibrillation that undergo standard of care procedure at the University of Kansas Hospital
|
Standard of care procedure as determined by treating physician for Atrial Fibrillation
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Outcomes of patients with persistent Atrial Fibrillation who undergo the standard of care hybrid procedure
大体时间:2 years
|
2 years
|
合作者和调查者
合作者
调查人员
- 首席研究员:Dhanunjaya Lakkireddy, MD, FACC、University of Kansas Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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