POLARx Cardiac Cryoablation System Post Market Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 19
- 主要终点
- Safety Event Free Rate
研究概览
简要总结
This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.
详细描述
The study will provide information on real-world usage of the Boston Scientific Cardiac Cryoablation System when used to perform pulmonary vein isolation (PVI) for the ablation treatment of atrial fibrillation (AF), according to the current and future guidelines and product indications for use. This may include but not limited to: repeated ablations to treat AF, concomitant or delayed adjunctive ablation strategies with other products and use of different diagnostic products to validate the results such as 3D mapping systems.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use;
- •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 study 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
- •Any known contraindication to an AF ablation or anticoagulation, including those listed in the instructions for use;
- •Subjects with indication for treatment of AF that is not according to current and future Guidelines and system indications for use;
- •Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause;
- •Known or pre-existing severe Pulmonary Vein Stenosis;
- •Evidence of myxoma, LA thrombus or intracardiac mural thrombus;
- •Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, PTCA, stent procedure) within 90 days prior to enrollment;
- •Implantable cardiac device procedures (e.g. PM, ICD, CRT) within 30 days prior to enrollment;
- •Implanted Left Atrial Appendage Closure device prior to the index procedure;
- •Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder;
- •Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings);
- •Presence of any pulmonary vein stents;
- •Active systemic infection;
- •Vena cava embolic protection filter devices and/ or known femoral thrombus;
- •Any previous history of cryoglobulinemia;
- •History of blood clotting or bleeding disease;
- •Any prior history of documented cerebral infarct, TIA or systemic embolism (excluding a post-operative deep vein thrombosis (DVT)) ≤ 180 days prior to enrollment;
- •Subjects who are hemodynamically unstable;
- •The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
- •Life expectancy ≤ 1 year per investigator's opinion;
- •Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion);
- •Unrecovered/unresolved Adverse Events from any previous invasive Procedure;
- •Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility.
结局指标
主要结局
Safety Event Free Rate
时间窗: 12 months
Freedom from procedure or device related adverse events after intervention, analyzed in all treatment and attempt subjects. The Primary Safety Endpoint is analyzed using data from all TREATMENT and ATTEMPT subjects including those with missing data. Subjects with missing data are censored at the appropriate timepoint in the KM analysis
Failure Free Rate
时间窗: 12 months
includes freedom from failure of intervention or more than one repeated procedures within 90 days post index procedure, or documented atrial fibrillation, new onset atrial flutter or atrial tachycardia between 91 days and 365 days post procedure
次要结局
- Documentation and Rate of Acute Procedural Success(Index Procedure)