Clinical trial NCT02757430: EnSite Precision™ 2.0 Registry
Official title: EnSite Precision™ Cardiac Mapping System and EnSite Precision™ Software v2.0 Observational Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmias
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-05-02
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient undergoing a cardiac EP mapping and ablation procedure, using the EnSite™ Precision Cardiac Mapping system, is considered eligible.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy
timeFrame: during procedure
measure: Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters
timeFrame: during procedure
measure: Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping
timeFrame: during procedure
measure: Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping
timeFrame: during procedure
measure: Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With TurboMap Module Mapping
timeFrame: during procedure
measure: Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters
timeFrame: during procedure
measure: Assessment of the EnSite Precision™ Software V2.0 in Terms of System Stability
timeFrame: during procedure
measure: Assessment of the EnSite Precision™ Software V2.0 in Terms of Unrecoverable Shifts
timeFrame: during procedure
Secondary outcomes:
measure: EnSite Precision™ Cardiac Mapping System Assessment
timeFrame: during procedure
measure: EnSite Precision™ Cardiac Mapping System Assessment
timeFrame: during procedure
measure: Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement
timeFrame: during procedure
measure: Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement
timeFrame: during procedure
Other outcomes:
Locations:
city: Asti
country: Italy
facility: Ospedale Cardinal Massaia di Asti
Study officials:
References: