EnSite Precision Observational Study



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/2/2019
Start Date:September 12, 2017
End Date:March 2020

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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

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.

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.

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
We found this trial at
7
sites
Saint Louis, Missouri 63110
Principal Investigator: Daniel Cooper, MD
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Saint Louis, MO
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Birmingham, Alabama 35211
Principal Investigator: Sahil Attawala, MD
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from
Birmingham, AL
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Boynton Beach, Florida 33425
Principal Investigator: Yoel Vivas, MD
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from
Boynton Beach, FL
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201 East Oak Avenue
Jonesboro, Arkansas 72401
Principal Investigator: Devi Nair, MD
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from
Jonesboro, AR
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Lincoln, Nebraska 68506
Principal Investigator: Robert Percell, MD
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from
Lincoln, NE
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Little Rock, Arkansas 72205
Principal Investigator: Blake Norris, MD
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from
Little Rock, AR
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Milwaukee, Wisconsin 14450
Principal Investigator: Firas Zahwe, MD
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from
Milwaukee, WI
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