Clinical trial NCT03260244: EnSite Precision Observational Study
Official title: A Clinical Evaluation Using EnSite Precision Cardiac Mapping System (Software Version 2.0.1 or Higher) in a Real-World Environment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmia
Keywords: atrial fibrillation
atrial flutter
supraventricular tachycardia
ventricular tachycardia
premature ventricular contractions
cardiac mapping system
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2017-08-24
Enrollment: 1065
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The intended population for this clinical study is patients over the age of 18 years who are eligible for a cardiac electrophysiology mapping and radiofrequency ablation procedure using the EnSite Precision™ Cardiac Mapping System.

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.

Eligibility criteria: 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 outcomes:
measure: Rate of Acute Success Based on Pre-defined Procedural Endpoints
timeFrame: during procedure
measure: Freedom From Arrhythmia Recurrence
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Baptist Medical Center Princeton
state: Alabama
city: Jonesboro
country: United States
facility: Cardiology Associates of North East Arkansas
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Cardiology
state: Arkansas
city: Boynton Beach
country: United States
facility: Bethesda Memorial Hospital
state: Florida
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Lincoln
country: United States
facility: Bryan LGH Medical Center East
state: Nebraska
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
Study officials:
affiliation: Abbott
name: Kristin Ruffner, PhD
role: STUDY_DIRECTOR
References: