A Pilot Study on the Role pf Ganglionated Plexus Ablation for Catheter Ablation of Atrial Fibrillation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Freedom from atrial fibrillation/flutter/tachycardia (>30 seconds) off antiarrhythmic medication at the end of 12 months following the index ablation procedure.
研究概览
简要总结
This study evaluates the effect of catheter ablation of ganglionated plexi (GP) for the treatment of adult patients with atrial fibrillation heart arrhythmias. The location of GP will be demonstrated by a novel nuclear imaging cardiac camera. 3D images from the cardiac camera will guide the GP ablation procedure.
详细描述
Catheter ablation procedures are nowadays routine procedures in patients with drug-refractory atrial fibrillation (AF). However, ablation success for patients even in the early stages of AF is currently only around 70% and may require multiple procedures.
The intrinsic cardiac autonomic nervous system (ANS), which forms a neural network, has been shown to be a critical element responsible for the initiation and maintenance of AF. Autonomic inputs to the heart converge at several locations; these convergence points are typically embedded in the epicardial fat pads and form ganglionated plexi (GP) that contain autonomic ganglia and nerves. In human hearts, there are at least 7 GP and the 4 major left atrial GP are located around the antrum of the pulmonary veins (PVs). High-frequency stimulation (HFS; 20 Hz, 10-150 V and pulse width 1-10 ms) can localize GP during an invasive electrophysiology (EP) study.
A novel dedicated cardiac nuclear imaging camera with solid-state detectors (D-SPECT, Spectrum Dynamics) has demonstrated significantly improved sensitivity and image resolution and can provide novel imaging information on previously 'invisible' structures like the GP. Using this 3D image information to guide GP ablation could significantly facilitate AF ablation and result in improved ablation outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal or early persistent atrial fibrillation with ongoing AF for less than 1 week
- •Able to give written informed consent
- •Age >18 years old and ≤ 80 years
- •Fulfil established clinical criteria for catheter ablation of atrial fibrillation
- •Normal left ventricular (LV) ejection fraction and no evidence of significant structural heart disease
排除标准
- •Reversible cause of atrial fibrillation
- •Recent cardiovascular event including transient ischaemic attack (TIA)
- •Intolerance or unwillingness to oral anticoagulation with Warfarin
- •Bleeding disorder
- •Contraindication to computed tomography (CT) scan
- •Presence of intracardiac thrombus
- •Vascular disorder preventing access to femoral veins
- •Cardiac congenital abnormality
- •Severe, life threatening non cardiac disease
- •Active malignant disease or recent (<5 years) malignant disease
- •Presence of atrial septal defect (ASD) or patent foramen ovale (PFO) closure device
- •Unable or unwilling to comply with follow-up requirements
- •Patients on amiodarone until less than 3 months prior to the screening visit
- •Left atrium size > 5.5 cm on parasternal diameter in transthoracic echocardiography (TTE)
- •Renal impairment
- •Pregnancy
研究组 & 干预措施
Image guided GP ablation
Use of cardiac nuclear imaging data to guide GP ablation procedures.
干预措施: Image guided GP ablation (Procedure)
Image guided GP ablation
Use of cardiac nuclear imaging data to guide GP ablation procedures.
干预措施: D-SPECT dedicated cardiac nuclear camera (Device)
结局指标
主要结局
Freedom from atrial fibrillation/flutter/tachycardia (>30 seconds) off antiarrhythmic medication at the end of 12 months following the index ablation procedure.
时间窗: 12 months post the index ablation procedure.
Termination of atrial fibrillation during image guided ablation
时间窗: At the time of the ablation procedure.
次要结局
- Atrial fibrillation/flutter/tachycardia (>30 seconds) burden at 12 months post the index ablation procedure.(12 months from the index ablation procedure.)
- Time to first recurrence of atrial fibrillation/flutter/tachycardia (>30 seconds)(Up to 12 months from the index ablation procedure)
- Freedom from atrial fibrillation on previously failed antiarrhythmic medication(12 months from the index ablation procedure.)
- Left atrial transport function(6 months and 12 months post the index ablation procedure)