EnSite Precision™ 2.0 Registry

Completed

Conditions: Cardiac Arrhythmias

Registration Number: NCT02757430

Lead Sponsor: Abbott Medical Devices

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 515

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy	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	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	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	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	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	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	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	during procedure	summarizing the count and percentage of patients with unrecoverable shifts

Secondary Outcome Measures

Name	Time	Method
EnSite Precision™ Cardiac Mapping System Assessment	during procedure	Overall procedure time summarized using mean and standard deviation
Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement	during procedure	Count and percentage of subjects where the AutoMark feature was easy to use