EnSite Precision™ Cardiac Mapping System and EnSite Precision™ Software v2.0 Observational Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 515
- 试验地点
- 1
- 主要终点
- Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy
研究概览
简要总结
The objective of this registry is to assess and characterize the use and performance of the EnSite Precision™ Cardiac Mapping System and the EnSite Precision™ Software V2.0 in a variety of electrophysiological (EP) procedures and clinical settings. This registry will assess the clinical performance of the system in a controlled, real-world environment after commercial release.
Up to 500 subjects will be enrolled in up to 50 sites worldwide.
Data will be collected at enrollment/baseline, procedure and pre-discharge. There is no long-term follow-up required for this registry.
The anticipated registry enrollment is about 6-7 months.
详细描述
The use of the EnSite Precision™ Cardiac Mapping System will be assessed by collecting feedback from physicians/operators through specific questions.
The performance of the EnSite Precision™ Cardiac Mapping System will be assessed by collecting procedure data and adverse events.
A detailed Data Management Plan will be established to ensure consistency of the data. This document will include procedures used for data review, database cleaning, and issuing and resolving data queries. If appropriate, the Data Management Plan may be updated throughout the registry duration. All revisions will be tracked and document controlled.
Case Report Form data will be captured in a validated electronic database management system hosted by St. Jude Medical.
Centralized monitoring will occur through routine internal data review. This monitoring is designed to identify missing and inconsistent data, data outliers, and potential protocol deviations that may be indicative of site non-compliance. On-site monitoring may occur at the discretion of the sponsor.
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
- •Patients indicated for a cardiac EP study and ablation procedure using a 3D mapping system
- •Over 18 years of age
- •Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations
排除标准
- •Contraindication to anticoagulation
- •Presence of thrombus
- •Implanted with mechanical prosthetic heart valve
- •Recent (<3 months) myocardial Infarction or unstable angina or coronary artery by-pass
- •Pregnant or nursing
- •Individuals whose willingness to volunteer in a registry, in the judgment 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
Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy
时间窗: during procedure
summarizing the count and percentage of patients with accurate geometry
Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters
时间窗: during procedure
mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: Manual AutoMap™ TurboMap™
Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping
时间窗: during procedure
mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: Manual
Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping
时间窗: during procedure
mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: AutoMap module
Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With TurboMap Module Mapping
时间窗: during procedure
mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: TurboMap module
Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters
时间窗: during procedure
mapping points collected and used will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate)
Assessment of the EnSite Precision™ Software V2.0 in Terms of System Stability
时间窗: during procedure
summarizing the count and percentage of patients with overall system stability
Assessment of the EnSite Precision™ Software V2.0 in Terms of Unrecoverable Shifts
时间窗: during procedure
summarizing the count and percentage of patients with unrecoverable shifts
次要结局
- EnSite Precision™ Cardiac Mapping System Assessment(during procedure)
- Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement(during procedure)