NCT02129842已完成不适用
A Prospective, Non-randomized, Double Blind Multicenter Study to Assess Endothelial Function Using Endo-PAT2000 and Its Correlation to Clinical Outcome Following Ablation in Patients With Atrial Fibrillation
Itamar-Medical, Israel6 个研究点 分布在 4 个国家目标入组 150 人开始时间: 2014年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Freedom from AF/AFL/AT off antiarrhythmic drugs therapy
研究概览
简要总结
The purpose of this study is to assess whether normal endothelial function in patients with Atrial Fibrillation undergoing ablation procedure increases the chances of a favorable clinical outcome and maintaining sinus rhythm following ablation
详细描述
In the recent years, increasing evidence is linking inflammation to AFib. In addition, it has been shown that ablation improves endothelial function, suggesting that AFib might be associated with the etiology of endothelial dysfunction.
The objective of this study is to assess endothelial function using Endo-PAT2000 and its correlation to clinical outcome following ablation of patients with Atrial Fibrillation (AFib).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •All patients with AF considered eligible for ablation treatment may be included in this study (following unsuccessful attempts with AAD).
- •Patients on optimal anticoagulation therapy
- •The minimum AF documentation required as defined by the Heart Rhythm Society
排除标准
- •Patients age below 18 years
- •Cases with extremely abnormal anatomy (i.e., inverted heart)
- •Moderate or severe mitral valve disease or mitral prosthetic valve
- •Ejection fraction less than 30%
- •Left atrial anteroposterior diameter more than 50 mm evaluated by echo or CT data (up to 6 months old)..
- •Previous atrial fibrillation ablation occurred less than 6 months prior
- •Left atrium thrombus
- •Acute infective disease or sepsis in the last 3 months
- •Acute myocardial infarction in last 3 months
- •Reduced expectancy of life (less than 12 months)
- •Patient participating in another clinical study that investigates a drug or device unless prior approval is given by the sponsor
- •Psychologically unstable patient or denies to give informed consent
- •Deformities of the digits of the upper extremities, which preclude adequate signal acquisition
- •Patients under the effect of short-acting Nitroglycerin (3 hours washout period)
- •Patient suffering from a medical condition prohibiting blood flow occlusion in both arms
结局指标
主要结局
Freedom from AF/AFL/AT off antiarrhythmic drugs therapy
时间窗: 12 months
次要结局
- Acute procedural success: Pulmonary veins isolation(12 months)
- 75% reduction in the number/duration of AFib episodes(12 months)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Improvement in Endothelial Dysfunction After Initiation of Anti-arrhythmic Therapy in Atrial Fibrillation PatientsAtrial FibrillationNCT04128878Samir Saba12
已完成
不适用
A clinical study of endothelial function and cardiac function and cardio-renal biomarkers in chronic kidney diseasechronic kidney diseaseJPRN-UMIN000003614Okayama university Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences300
已完成
不适用
Follow-up study to evaluate the impact of atrial fibrillation on mortality and the occurrence of complications in patients with transcatheter aortic valve implantatioZ95.4Presence of other heart-valve replacementDRKS00011798niversitätsklinik für Kardiologie und Angiologie257
已完成
不适用
Assessment of Arterial Enothelial Functon by using ASV in Patients with Chronic Heart FailureChronic Heart FailureJPRN-UMIN000017199Hokkaido University Graduate School of Medicine70
尚未招募
不适用
Analysis of endothelial function of patients with large vessel vasculitis and ANCA-associated small vessel vasculitisMicroscopic polyangiitisWegener granulomatosisM31.6M31.5M31.3M31.7M30.1Giant cell arteritis with polymyalgia rheumaticaOther giant cell arteritisPolyarteritis with lung involvement [Churg-Strauss]DRKS00005139niversitätsklinikum Jena100