EnSite Precision™ 2.0 Registry

Abbott Medical Devices515 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

515

Conditions

Cardiac Arrhythmias

Interventions

Cardiac AblationPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ospedale Cardinal Massaia di Asti

Asti, Italy

Outcomes

Primary Outcomes

Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy

summarizing the count and percentage of patients with accurate geometry

Time frame: during procedure

Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters

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™

Time frame: during procedure

Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping

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

Time frame: during procedure

Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping

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

Time frame: during procedure

Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With TurboMap Module Mapping

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

Time frame: during procedure

Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters

mapping points collected and used will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate)

Data from ClinicalTrials.gov

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Secondary Outcomes

EnSite Precision™ Cardiac Mapping System Assessment

Count and percentage of subjects in whom the mapping system was reported to be excellent, very good, good, poor and N/A

Time frame: during procedure

EnSite Precision™ Cardiac Mapping System Assessment

Overall procedure time summarized using mean and standard deviation

Time frame: during procedure

Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement

Count and percentage of subjects where the AutoMark feature assisted in identifying gaps in lesion lines

Time frame: during procedure

Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement

Count and percentage of subjects where the AutoMark feature was easy to use

Time frame: during procedure