EnSite Precision Observational Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Clinical Evaluation Using EnSite Precision Cardiac Mapping System (Software Version 2.0.1 or Higher) in a Real-World Environment

Conditions
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Cardiac Arrhythmia

Intervention / Treatment
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* Procedure: cardiac mapping and radiofrequency ablation procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indicated for a cardiac EP mapping and RF ablation procedure using a 3D mapping system per IFU 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cardiac mapping and radiofrequency ablation procedure|It is a minimally invasive procedure which can be performed using either general or conscious sedation. During catheter ablation, catheters (narrow, flexible tubes) are inserted into a blood vessel, often through a site in the groin (upper thigh) or neck, and guided through the vein until they reach the heart. Small electrodes on the tip of the catheters stimulate and record the heart's activity. This test, called an electrophysiology study (EPS), allows the doctor to pinpoint the exact location of the short circuit. Another word for pinpointing the exact location of the short circuit is 'mapping', for which precision is a key requirement to maximize a successful outcome. Once the location is confirmed, the short circuit is either destroyed (to reopen the electrical pathway) or blocked (to prevent it from sending faulty signals to the rest of the heart).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of subjects that used EnSite™ AutoMap and AutoMark module | Overall usage of EnSite™ AutoMap Module. This will be summarized by the number and proportion of subjects with a procedure that use EnSite™ AutoMap. Overall usage of AutoMark module. This will be summarized by the number and proportion of subjects with a procedure that use AutoMark. | during procedure | 
| Summary of EnSite™ Automap and AutoMark Module software settings used per arrhythmia | Among the subjects with EnSite™ AutoMap and AutoMark module features used during the procedure, the settings of EnSite™ AutoMap and AutoMark features will be summarized descriptively by each arrhythmia, as number and proportion or mean and standard deviation as appropriate. | during procedure | 
| Mapping time associated with (re-)mapping one or multiple arrhythmias per catheter type used in a single subject | Mapping time will be summarized (e.g. as mean, median, standard deviation, minimum and maximum) across arrhythmia types and for each type of arrhythmia per catheter, as appropriate for the different map types. | during procedure | 
| Used Points per Minute per catheter type stratified by arrhythmia type and mapping type | Mapping points per minute used will be summarized (e.g. as mean, median, standard deviation, minimum and/or maximum) across arrhythmia types and for each type of arrhythmia per catheter as appropriate, for the different map types | during procedure | 
| Rate of acute success based on pre-defined procedural endpoints | The number and proportion of subjects with acute success will be summarized. | during procedure | 
| Freedom from arrhythmia recurrence | 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. | 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 | 
| Number of repeat ablations up to 12 months. | This will be summarized as the total count of repeat ablations up to 12 months and the total number of subjects who experience at least one repeat ablation up to 12 months among all subjects in analysis population. | 1 year | 
| Summary of NavX Patch placement locations used | The number and proportion of subjects with NavX patches (Surface Electrode Patches) placed by location | during procedure | 
| Number of gaps in lesions identified during the procedure that require touch-up ablation | The number and proportion of subjects with gaps in lesions identified will be summarized and reported. The summary of number of gaps identified will be reported. The number and proportion of subjects where the AutoMark Module assisted in identifying these gaps will be summarized and reported. | during procedure | 
| Changes in EQ-5D quality of life score at 6 and 12 months | Changes in EQ-5D at 6 months from baseline, and changes in EQ-5D score at 12 months from baseline will be summarized. | 1 year | 
| Number of unscheduled visits and hospitalizations due to arrhythmia | The number of unscheduled visits due to arrhythmia, or hospitalizations due to arrhythmia will be summarized per subject and presented as the number of subjects | 1 year | 
| Overall procedure time | Overall procedure time for the index procedure will be summarized e.g. as mean, standard deviation, minimum and/or maximum. Procedure time will be derived as (Procedure stop time (Last catheter out) - Procedure start time (first catheter in)). | during procedure | 
| Overall system stability | Proportion of subjects with the system stable throughout the procedure. System stability will be based on the opinion of the investigator. | during procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia, premature ventricular contractions, cardiac mapping system