NL-OMON50243已完成不适用
Clinical Evaluation of the StablePoint Catheter and Force-Sensing System for Paroxysmal Atrial Fibrillation - NEWTON AF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* History of recurrent symptomatic Paroxysmal Atrial Fibrillation (PAF),
- •defined as atrial fibrillation (AF) that terminates spontaneously or with
- •intervention (either procedure or drug therapy) within seven days of onset.
- •Minimum documentation includes the following:
- •o a physician*s note indicating recurrent self-terminating atrial fibrillation
- •(AF) which includes at least two symptomatic AF episodes in the patient*s
- •history within the last 6 months prior to enrollment, and
- •o any electrocardiographically documented AF episode within 12 months prior to
- •enrollment.
- •* Subjects who are eligible for an ablation procedure for PAF according to 2017
- •HRS expert consensus statement on catheter ablation of atrial fibrillation;
- •* Subjects refractory or intolerant to at least one class I or class III
- •antiarrhythmic medication or contraindicated to any class I or III medications;
- •* Subjects who are willing and capable of providing informed consent;
- •* Subjects who are willing and capable of participating in all testing
- •associated with this clinical investigation at an approved clinical
- •investigational center;
- •* Subjects whose age is 18 years or above, or who are of legal age to give
- •informed consent specific to state and national law.
排除标准
- •* Subjects with New York Heart Association (NYHA) Class III or IV heart failure
- •< 180 days prior to enrollment
- •* Left atrial diameter > 5.0 cm or left atrial volume >50 ml/m² indexed based
- •on the most recent echocardiography
- •* Left ventricular ejection fraction < 35% based on the most recent
- •echocardiogram
- •* Continuous AF lasting longer than seven (7) days
- •* Subjects who have undergone any previous left atrial cardiac ablation (RF,
- •Cryo, surgical)
- •* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or
- •reversible or non-cardiac cause
- •* Subjects who have undergone any cardiac ablation or any surgery within 30
- •days prior to enrollment
- •* Currently implanted with a pacemaker, ICD, CRT device, or an implanted
- •arrhythmia loop recorder
- •* Active systemic infection
- •* Unstable angina or ongoing myocardial ischemia
- •* Myocardial Infarction (MI) within 90 days prior to enrollment
- •* Evidence of myxoma, left atrial thrombus or intracardiac mural thrombus
- •* Previous cardiac surgery (i.e. ventriculotomy, atriotomy, CABG, PTCA, PCI,
- •coronary stenting procedures) * 90 days prior to enrollment.
- •* Severe valvular disease, including mechanical prosthetic mitral or tricuspid
- •heart valves (patients with successful mitral valve repair allowed * annular
- •ring constitutes repair);
- •* Any prior history of documented cerebral infarct, TIA or systemic embolism
- •[excluding a post-operative deep vein thrombosis (DVT)] <180 days prior to
- •* Moderate or severe mitral stenosis (severity assessed on the most recent TTE
- •*180 days prior to enrollment. Defined as pulmonary artery systolic pressure
- •* Presence of left atrial appendage closure device
- •* Interatrial baffle, closure device, patch, or patent foramen ovale (PFO)
- •* Subjects who, in the judgment of the investigator, have a life expectancy of
- •less than two (2) years
- •* Women of childbearing potential who are, or plan to become, pregnant during
- •the time of the study (method of assessment upon investigator*s discretion)
- •* Amiodarone use within 60 days prior to enrollment
- •* Any carotid stenting or endarterectomy
- •* Stage 3B renal disease or higher (estimated glomerular filtration rate, eGFR
- •<45 mL/min)
- •* Known coagulopathy disorder (e.g. von Willebrand*s disease, hemophilia)
- •* Any known contraindication to an AF ablation
- •* Any known contraindication for anticoagulation (e.g. patients unable to
- •receive heparin or an acceptable alternative to achieve adequate
- •anticoagulation)
- •* Vena cava embolic protection filter devices and/or known femoral thrombus
- •that prevents catheter insertion from the femoral approach
- •* Known sensitivity to contrast media (if needed during the procedure) that
- •cannot be controlled with pre-medication
- •* Rheumatic Heart Disease
- •* Presence of intramural thrombus, tumor or other abnormality that precludes
- •vascular access, or manipulation of the catheter
- 另有 6 项未显示
研究者
相似试验
已完成
不适用
The validation of a new catheter for intermittent Self-Catheterization in female patients; proof of principlesAcontractile or underactive bladder dysfunction: inability to empty the bladder10004994NL-OMON42152ovoqare B.V.10
已完成
不适用
A clinical evaluation of new catheter for continuous peripheral nerve blockosteoarthritisJPRN-UMIN000019630Department of Anesthesiology , Wakayama medical school40
已完成
4 期
Comparative study of the conventional catheter and the new device for cannulation in difficult ERCP case: a multicentre, crossover, randomised controlled trial.pancreatobliary diseaseJPRN-UMIN000026232Department of Gastroenterology. Fukushima Medical University Aizu Medical center.64
已完成
不适用
The Efficacy and Safety of Diagnostic Catheter for Cerebrovascular Disease using GENOSS InitiatorTMKCT0005718Soon Chun Hyang University Hospital Cheonan420
尚未招募
Unknown
Impact of Catheter Stabilization on Catheter Micro-Motion and FunctioPhlebitisACTRN12623000328673Griffith University40