EnSite Precision Observational Study

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT03260244

Collaborator

(none)

1,065

Enrollment

Locations

30.6

Actual Duration (Months)

152.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrhythmia	Procedure: cardiac mapping and radiofrequency ablation procedure

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.

Study Design

Study Type:

Observational

Actual Enrollment :

1065 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 12, 2017

Actual Primary Completion Date :

Jan 17, 2020

Actual Study Completion Date :

Mar 31, 2020

Outcome Measures

Primary Outcome Measures

Summary of subjects that used EnSite™ AutoMap and AutoMark module [during procedure]
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.
Summary of EnSite™ Automap and AutoMark Module software settings used per arrhythmia [during procedure]
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.
Mapping time associated with (re-)mapping one or multiple arrhythmias per catheter type used in a single subject [during procedure]
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.
Used Points per Minute per catheter type stratified by arrhythmia type and mapping type [during procedure]
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
Rate of acute success based on pre-defined procedural endpoints [during procedure]
The number and proportion of subjects with acute success will be summarized.
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.
Number of repeat ablations up to 12 months. [1 year]
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.
Summary of NavX Patch placement locations used [during procedure]
The number and proportion of subjects with NavX patches (Surface Electrode Patches) placed by location
Number of gaps in lesions identified during the procedure that require touch-up ablation [during procedure]
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.
Changes in EQ-5D quality of life score at 6 and 12 months [1 year]
Changes in EQ-5D at 6 months from baseline, and changes in EQ-5D score at 12 months from baseline will be summarized.
Number of unscheduled visits and hospitalizations due to arrhythmia [1 year]
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
Overall procedure time [during procedure]
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)).
Overall system stability [during procedure]
Proportion of subjects with the system stable throughout the procedure. System stability will be based on the opinion of the investigator.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baptist Medical Center Princeton	Birmingham	Alabama	United States	35211
2	Cardiology Associates of North East Arkansas	Jonesboro	Arkansas	United States	72401
3	Arkansas Cardiology	Little Rock	Arkansas	United States	72205
4	Bethesda Memorial Hospital	Boynton Beach	Florida	United States	33435
5	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
6	Bryan LGH Medical Center East	Lincoln	Nebraska	United States	68506
7	Aurora Medical Group	Milwaukee	Wisconsin	United States	53215