EnSite Precision™ 2.0 Registry

NCT ID: NCT02757430

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 515 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-30
• Study Completion Date: 2017-07-15

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.

Conditions

Cardiac Arrhythmias

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Cardiac Ablation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ospedale Cardinal Massaia di Asti

Asti, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

SJM-CIP-10111

Identifier Type: -

Identifier Source: org_study_id