NCT02553239终止不适用
CoolLoop Paroxysmal Atrial Fibrillation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- afreeze GmbH
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Safety of catheter ablation using the CoolLoop® cryoablation catheter determined by the number of patients with device-, or procedure-related serious adverse events.
研究概览
简要总结
This clinical investigation evaluates the safety of cryoablation (sclerotherapy of muscle tissue of the heart by freezing) in paroxysmal atrial fibrillation with the newly developed CoolLoop® cryoablation catheter.
A further aim of the investigation is the evaluation of the efficacy and average duration of the applied procedure.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 - 70 years
- •symptomatic paroxysmal Atrial fibrillation (AF)
- •a minimum of three episodes of paroxysmal AF
- •at least one episode of paroxysmal AF within the last 6 months documented by ECG
- •signed and dated informed consent documented by the patient
- •female subjects of childbearing potential can be included, if they: agree to use, and be able to comply with, effective contraception without interruption, from study enrollment, throughout hospitalization and until 12 weeks after catheter ablation
排除标准
- •left atrial diameter > 50 mm in the short axis as assessed by transthoracic echocardiography
- •advanced structural heart disease including
- •moderate-to-severe valvular stenosis or regurgitation,
- •previous valve replacement or valve repair,
- •congenital heart disease,
- •left ventricular ejection fraction < 45% during sinus rhythm,
- •congestive heart failure New York Heart Association (NYHA) III or IV,
- •coronary artery bypass graft surgery within the last 3 months
- •chronic obstructive pulmonary disease treated with beta-sympathomimetic drugs
- •severe respiratory insufficiency
- •known bleeding diathesis
- •intolerance of Heparin and/or intolerance of oral anticoagulation
- •previous AF ablation
- •permanent pacemaker
- •left atrial thrombus
- •intramural or intracardiac thrombus or tumor, or other conditions that may result in difficulties advancing the CoolLoop® cryoablation catheter into the left atrium
- •access to the vascular system via the right or left femoral vein is not possible
- •transseptal puncture cannot be achieved due to a previous operation or intervention at the interatrial septum (e.g. closure of a patent foramen ovale or atrial septal defect)
- •contraindication for transesophageal echocardiography or fluoroscopy
- •impaired renal function (glomerular filtration rate <30 ml/min.)
- •history or increased risk of intracranial hemorrhage
- •history of cerebral ischemic stroke or transient ischemic cerebral attacks within the last 180 days prior to enrolment
- •severe comorbidity
- •hyperthyreosis
- •any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he / she were to participate in the study or confound the ability to interpret data from the study
- •any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form
- •pregnant or lactating females
- •other severe conditions, which makes the patient unsuitable to participate in the study, as judged by the Investigator
- •live-expectancy < 1 year
- •the patient is active in another clinical trial
研究组 & 干预措施
Cryoablation
Experimental
Cryoablation with the CoolLoop® catheter
干预措施: CoolLoop® (Device)
结局指标
主要结局
Safety of catheter ablation using the CoolLoop® cryoablation catheter determined by the number of patients with device-, or procedure-related serious adverse events.
时间窗: 12 months follow-up period
次要结局
- Measurement of freedom from Atrial Fibrillation (AF) episodes following left atrial catheter ablation using the CoolLoop cryoablation catheter.(from 3 to 12 months after catheter ablation)
- Assessment of acute efficacy of catheter ablation defined by Pulmonary Vein (PV) Isolation.(from start to end of ablation procedure)
- Assessment of the CoolLoop catheter procedure time(from start to end of ablation procedure)
- Assessment of the CoolLoop cryoablation time(from start to end of ablation procedure)
- Assessment of the CoolLoop fluoroscopy time(from start to end of ablation procedure)
- Assessment of serious and non-serious Adverse Events (SAEs/AEs)(12 months follow-up period)
研究者
研究点 (8)
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