EnSite Precision Observational Study

Completed

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Rate of Acute Success Based on Pre-defined Procedural Endpoints	during procedure	The number and proportion of subjects with acute success will be summarized. Acute success was defined as the physician's goal or intention for the procedure.
Freedom From Arrhythmia Recurrence	From date of procedure until the date of first documented arrhythmia recurrence or date of study completion or withdrawal for any cause, whichever came first, assessed up to 12 months	This analysis will be performed using the Kaplan-Meier (KM) analyses. The start date is the date of the index procedure. For subjects who do not experience an event, their follow up duration will be defined from the start date to the date of death, withdrawal, or last follow-up, whichever occurred later.

Secondary Outcome Measures

Name	Time	Method

Locations (7): Arkansas Cardiology
🇺🇸
Little Rock, Arkansas, United States
Cardiology Associates of North East Arkansas
🇺🇸
Jonesboro, Arkansas, United States
Bryan LGH Medical Center East
🇺🇸
Lincoln, Nebraska, United States
Baptist Medical Center Princeton
🇺🇸
Birmingham, Alabama, United States
Bethesda Memorial Hospital
🇺🇸
Boynton Beach, Florida, United States
Barnes-Jewish Hospital
🇺🇸
Saint Louis, Missouri, United States
Aurora Medical Group
🇺🇸
Milwaukee, Wisconsin, United States