EnSite Precision™ 2.0 Registry

Cardiac Arrhythmias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02757430
• Other study ID #: SJM-CIP-10111
• Status: Completed
• Start date: August 30, 2016
• Est. completion date: July 15, 2017

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: July 15, 2017
• Est. primary completion date: July 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias

Intervention

Procedure:
• Cardiac Ablation

Locations

Country	Name	City	State
Italy	Ospedale Cardinal Massaia di Asti	Asti

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	EnSite Precision™ Cardiac Mapping System Assessment	Overall procedure time summarized using mean and standard deviation	during procedure
Secondary	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
Secondary	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