NL-OMON54978已完成不适用
POLARx Cardiac Cryoablation System Post Market Clinical Follow-up study - POLAR-ICE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
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
- •1. Subjects indicated for the treatment of AF with the cryoablation system
- •according to current and future Guidelines and system indications for use;
- •2. Subjects who are willing and capable of providing informed consent;
- •3. Subjects who are willing and capable of participating in all testing
- •associated with this clinical study at an approved clinical investigational
- •4. 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
- •1. Any known contraindication to an AF ablation or anticoagulation, including
- •those listed in the instructions for use;
- •2. Subjects with indication for treatment of AF that is not according to
- •current and future Guidelines and system indications for use;
- •3. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or
- •any other reversible or non-cardiac cause;
- •4. Known or pre-existing severe Pulmonary Vein Stenosis;
- •5. Evidence of myxoma, LA thrombus or intracardiac mural thrombus;
- •6. Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, PTCA,
- •stent procedure) within 90 days prior to enrollment;
- •7. Implantable cardiac device procedures (e.g. PM, ICD, CRT) within 30 days
- •prior to enrollment;
- •8. Implanted Left Atrial Appendage Closure device prior to the index procedure;
- •9. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO)
- •10. Subjects with severe valvular disease OR with a prosthetic - mechanical or
- •biological - heart valve (not including valve repair and annular rings);
- •11. Presence of any pulmonary vein stents;
- •12. Active systemic infection;
- •13. Vena cava embolic protection filter devices and/ or known femoral thrombus;
- •14. Any previous history of cryoglobulinemia;
- •15. History of blood clotting or bleeding disease;
- •16. Any prior history of documented cerebral infarct, TIA or systemic embolism
- •(excluding a post-operative deep vein thrombosis (DVT)) <= 180 days prior to
- •enrollment;
- •17. Subjects who are hemodynamically unstable;
- •18. The subject is unable or not willing to complete follow-up visits and
- •examination for the duration of the study;
- •19. Life expectancy <= 1 year per investigator*s opinion;
- •20. Women of childbearing potential who are, or plan to become, pregnant during
- •the time of the study (method of assessment upon investigator*s discretion);
- •21. Unrecovered/unresolved Adverse Events from any previous invasive Procedure;
- •22. 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.
研究者
相似试验
已完成
不适用
POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART)Paroxysmal Atrial FibrillationNCT05282823Boston Scientific Corporation295
已完成
不适用
POLARx Cardiac Cryoablation System StudyAtrial FibrillationNCT04250714Boston Scientific Corporation400
已完成
Unknown
CRYO-SCAR studyesophageal cancerJPRN-jRCT1080225331ational Cancer Center Hospital East15
已完成
不适用
Cryoablation System FIM/CE Mark StudyAtrial FibrillationNCT03723070Boston Scientific Corporation88
招募中
不适用
Study of the ClariFix Cryoablation Device in Patients with Chronic Rhinitis - New ZealandChronic rhinitisRespiratory - Other respiratory disorders / diseasesACTRN12614000468628Arrinex, Inc.30