EnSite Precision™ 2.0 Registry

EnSite Precision™ Cardiac Mapping System and EnSite Precision™ Software v2.0 Observational Registry

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrhythmias
• Intervention / Treatment: Procedure: Cardiac Ablation

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.

• Study Type: Observational
• Enrollment (Actual): 515

Contacts and Locations

Study Locations

• Italy
  • Asti, Italy, 14100
    • Ospedale Cardinal Massaia di Asti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy	summarizing the count and percentage of patients with accurate geometry	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™	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	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	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	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)	during procedure
Assessment of the EnSite Precision™ Software V2.0 in Terms of System Stability	summarizing the count and percentage of patients with overall system stability	during procedure
Assessment of the EnSite Precision™ Software V2.0 in Terms of Unrecoverable Shifts	summarizing the count and percentage of patients with unrecoverable shifts	during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	during procedure
EnSite Precision™ Cardiac Mapping System Assessment	Overall procedure time summarized using mean and standard deviation	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	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	during procedure

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2016
• Primary Completion (Actual): July 15, 2017
• Study Completion (Actual): July 15, 2017

Study Registration Dates

• First Submitted: April 8, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Actual): May 6, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: SJM-CIP-10111