NCT06293430尚未招募不适用
Registry on Luma Vision's VERAFEYE System in Catheter Ablation and Left Atrial Appendage Closure Procedures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Acute procedural success rates during the index procedure
研究概览
简要总结
The objective of the study is to compile real-world data on the use of the VERAFEYE System in standard of care atrial fibrillation (AF) ablation procedures and left atrial appendage closure (LAAC) procedures.
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
- •Subject is 18 years of age or of legal age to give informed consent specific to state and national law at the time of consent
- •Subjects is indicated for an atrial fibrillation ablation and/or a left atrial appendage closure procedure with the VERAFEYE System as navigation and imaging system, per physician discretion;
- •Subject is able to understand and willing to provide written informed consent
- •Subject is able and willing to complete all study assessments at an approved clinical investigational center
排除标准
- •Subjects who have undergone a previous cardiac ablation for the treatment of PAF/LAA Closure
- •Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
- •Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure)
- •Unrecovered/unresolved Adverse Events from any previous invasive procedure
- •Subjects who are currently enrolled in another study (except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments)
结局指标
主要结局
Acute procedural success rates during the index procedure
时间窗: During the procedure
A procedure will be defined as successful if all the following conditions occur during the case: * ability to create a 3D anatomical model with the VERAFEYE System and * completion of the necessary ablation applications for PAF/LAA Closure using the 3D anatomical model created with the VERAFEYE System
次要结局
未报告次要终点
研究者
相似试验
已完成
不适用
Feasibility Study on the VERAFEYE SystemAtrial Septal DefectAtrial ArrhythmiaLeft Atrial Appendage ClosureAtrial FibrillationNCT05931835LUMA Vision Ltd.18
Unknown
不适用
A Pilot Survey to Establish Vision Health Surveillance Indicators for Children and Adolescent in TaiwanVision StatusNCT03750630National Taiwan University Hospital10,000
招募中
不适用
Experiment on the Use of Innovative Computer Vision Technologies for Analysis of Medical Images in the Moscow Healthcare SystemAI (Artificial Intelligence)Mammary CancerCOVID-19Chest--DiseasesAbdomen DiseaseBrain DiseaseFractures, BoneLung CancerLesion X-RaysNCT04489992Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department133,000
已完成
不适用
Clinical Evaluation of the Next Generation Phaco SystemCataractNCT04332640Johnson & Johnson Surgical Vision, Inc.79
招募中
不适用
Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)Unresectable Hepatocellular Carcinoma (HCC)Liver Metastases From Colorectal Cancer (mCRC)NCT05967143Sirtex Medical845