EnSite Precision Observational Study

Abbott

Status: Completed

Conditions: Cardiac Arrhythmia

Treatments: Procedure: cardiac mapping and radiofrequency ablation procedure

Study type: Observational

Funder types: Industry

Identifiers

NCT03260244

SJM-CIP-10159

Details and patient eligibility

About

This document is a clinical investigation plan (CIP) for the EnSite Precision Observational Study.

This clinical study is intended to quantify and characterize the usage of the EnSite Precision™ Cardiac Mapping System (Software version 2.0.1 or higher) in a real-world environment. This study will be conducted in patients who are indicated for a cardiac electrophysiological (EP) mapping and radio frequency ablation procedure using a three-dimensional system.

Full description

The EnSite Precision™ Cardiac Mapping System is a newly developed system that introduces features such as Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) image integration, lesion marking automaticity, automatic mapping, and workflow flexibility to aid in the success of complex ablation procedures. Utilization of this system in the treatment of complex ablation procedures and its impact on patient outcomes is not well characterized. This clinical study is designed to collect a broad range of usage scenarios, therefore this clinical study has limited patient selection criteria and data collection is focused on EnSite Precision™ Cardiac Mapping System usage and patient outcomes.

The data collected from the procedure (performed per Instructions For Use (IFU) and per standard practice of the physician) as well as the 12 month follow up period enables the Sponsor to review the system's standard practice usage. This information will be added to the current knowledge and understanding of treatment options for patients with arrhythmias, which can assist the Sponsor to provide future recommendations for best practices to improve patient outcomes.

Enrollment: 1,065 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indicated for a cardiac electrophysiology mapping and radiofrequency ablation procedure using a 3-dimensional mapping system per Instructions for Use
• Over 18 years of age
• Able to provide informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule

Exclusion criteria

• Patients who are only presenting with:

  • Atrioventricular Nodal Reentrant Tachycardia (AVNRT)
  • Atrioventricular Reentrant Tachycardia (AVRT)

• Planned cryoablation procedure

• Implanted with a neurostimulator

• Contraindication to anticoagulation

• Known presence of cardiac thrombus

• Recent (<3 months) myocardial infarction or unstable angina or coronary artery by-pass

• Currently enrolled in a clinical study/investigation evaluating another device or drug that would confound the results of this study

• Pregnant or nursing

• Individuals whose willingness to volunteer in a study, in the judgement 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