EnSite Precision™ 2.0 Registry

Abbott

Status: Completed

Conditions: Cardiac Arrhythmias

Treatments: Procedure: Cardiac Ablation

Study type: Observational

Funder types: Industry

Identifiers

NCT02757430

SJM-CIP-10111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 515 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design