STOP Persistent AF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 49
- 主要终点
- Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.
研究概览
简要总结
To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent atrial fibrillation (AF).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by consecutive ECG recordings OR Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by an ECG recording and one doctor note indicating patient had symptoms consistent with AF
- •Failure or intolerance of at least one Class I or III antiarrhythmic drug
- •Age 18 or older (or older than 18 if required by local law)
排除标准
- •Left atrial diameter > 5.0 cm (anteroposterior)
- •Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
- •Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
- •Presence of any pulmonary vein stents
- •Presence of any pre-existing pulmonary vein stenosis
- •Pre-existing hemidiaphragmatic paralysis
- •Presence of any cardiac valve prosthesis
- •+3 and +4 mitral valve regurgitation or stenosis
- •Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding the consent date
- •Unstable angina
- •New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measure by acceptable cardiac testing (e.g. Transthoracic echocardiogram (TTE))
- •Primary pulmonary hypertension
- •Rheumatic heart disease
- •Thrombocytosis, thrombocytopenia
- •Any condition contraindicating chronic anticoagulation
- •Active systemic infection
- •Hypertrophic cardiomyopathy
- •Cryoglobulinemia
- •Uncontrolled hyperthyroidism
- •Any cerebral ischemic event (strokes or transient ischemic attacks (TIAs)) which occurred during the 6 month interval preceding the consent date
- •Any woman known to be pregnant or breastfeeding, or any woman of child bearing potential who is not on a reliable form of birth regulation method or abstinence
- •Life expectancy less than one year
- •Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
- •Known allergies or hypersensitivities to adhesives
- •Known drug or alcohol dependency
- •Unwilling or unable to comply fully with study procedures and follow-up
结局指标
主要结局
Percent of Subjects Free From Treatment Failure at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.
时间窗: 12 Months
Treatment failure is defined as any of the following components: * Acute procedural failure * Documented AF/atrial tachycardia (AT)/atrial flutter (AFL) after the 90 day blanking period * A reablation for the treatment of recurrent AF/AT/AFL after the 90 day blanking period * Class I or III antiarrhythmic drug (AAD) dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new Class I or III AAD after the 90 day blanking period. * Ablation using radiofrequency (RF) in the left atrium Blanking period is defined as the first 90 days after the index ablation procedure. Acute procedural failure is defined as: * Inability to isolate all accessible targeted pulmonary veins (minimally assessed for entrance block and, where assessable, exit block) during the index procedure * Left atrial non-PVI ablations including but not limited to, ablation of linear lesions complex fractionated electrograms or non-PV triggers
Percent of Subjects Free From a Primary Safety Event at 12 Months After the Pulmonary Vein Isolation (PVI) Ablation Procedure.
时间窗: 12 months
A primary safety event is defined as a serious procedure-related or serious system-related adverse event including the following: * Transient ischemic attack (within 7 days of ablation procedure) * Cerebrovascular accident (within 7 days of ablation procedure) * Major bleeding that requires transfusion (within 7 days of ablation procedure) * Cardiac perforation, tamponade or pericardial effusion (within 7 days of ablation procedure) * Pulmonary vein stenosis (\> 75% reduction within 12-months of ablation procedure) * Myocardial infarction (within 7 days of ablation procedure) * Phrenic nerve injury (unresolved at 12-months) * Atrio-esophageal fistula (within 12-months of ablation procedure) * Death (within 7 days of ablation procedure)
次要结局
- Change in Quality of Life Between Baseline and 12 Months: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)(Baseline and 12 months)
- Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Physical Component(Baseline and 12 months)
- Change in Quality of Life Between Baseline and 12 Months: Medical Outcome Study Short Form-12 (SF-12) Mental Component(Baseline and 12 months)