A Clinical Evaluation Using EnSite Precision Cardiac Mapping System (Software Version 2.0.1 or Higher) in a Real-World Environment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,065
- 试验地点
- 7
- 主要终点
- Rate of Acute Success Based on Pre-defined Procedural Endpoints
研究概览
简要总结
This document is a clinical investigation plan (CIP) for the EnSite Precision Observational Study.
This clinical study is intended to quantify and characterize the usage of the EnSite Precision™ Cardiac Mapping System (Software version 2.0.1 or higher) in a real-world environment. This study will be conducted in patients who are indicated for a cardiac electrophysiological (EP) mapping and radio frequency ablation procedure using a three-dimensional system.
详细描述
The EnSite Precision™ Cardiac Mapping System is a newly developed system that introduces features such as Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) image integration, lesion marking automaticity, automatic mapping, and workflow flexibility to aid in the success of complex ablation procedures. Utilization of this system in the treatment of complex ablation procedures and its impact on patient outcomes is not well characterized. This clinical study is designed to collect a broad range of usage scenarios, therefore this clinical study has limited patient selection criteria and data collection is focused on EnSite Precision™ Cardiac Mapping System usage and patient outcomes.
The data collected from the procedure (performed per Instructions For Use (IFU) and per standard practice of the physician) as well as the 12 month follow up period enables the Sponsor to review the system's standard practice usage. This information will be added to the current knowledge and understanding of treatment options for patients with arrhythmias, which can assist the Sponsor to provide future recommendations for best practices to improve patient outcomes.
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
- •Indicated for a cardiac electrophysiology mapping and radiofrequency ablation procedure using a 3-dimensional mapping system per Instructions for Use
- •Over 18 years of age
- •Able to provide informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule
排除标准
- •Patients who are only presenting with:
- •Atrioventricular Nodal Reentrant Tachycardia (AVNRT)
- •Atrioventricular Reentrant Tachycardia (AVRT)
- •Planned cryoablation procedure
- •Implanted with a neurostimulator
- •Contraindication to anticoagulation
- •Known presence of cardiac thrombus
- •Recent (<3 months) myocardial infarction or unstable angina or coronary artery by-pass
- •Currently enrolled in a clinical study/investigation evaluating another device or drug that would confound the results of this study
- •Pregnant or nursing
- •Individuals whose willingness to volunteer in a study, in the judgement of investigator or public authorities, could be unduly influenced by lack of or loss of the autonomy due to immaturity, or mental disability, or adverse personal circumstances, or hierarchical influence
结局指标
主要结局
Rate of Acute Success Based on Pre-defined Procedural Endpoints
时间窗: during procedure
The number and proportion of subjects with acute success will be summarized. Acute success was defined as the physician's goal or intention for the procedure.
Freedom From Arrhythmia Recurrence
时间窗: From date of procedure until the date of first documented arrhythmia recurrence or date of study completion or withdrawal for any cause, whichever came first, assessed up to 12 months
This analysis will be performed using the Kaplan-Meier (KM) analyses. The start date is the date of the index procedure. For subjects who do not experience an event, their follow up duration will be defined from the start date to the date of death, withdrawal, or last follow-up, whichever occurred later.
次要结局
未报告次要终点