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Trial record 2 of 18 for:    abbott ensite

EnSite Precision 2.1 Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03110146
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : February 12, 2019
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:

The objective is to demonstrate feasibility of new 'Magnetic Primary' catheter tracking algorithms within the Velocity Research Platform (VRP) by assessing the frequency of shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1

The secondary objective is to evaluate catheter rendering in the VRP system.

Condition or disease Intervention/treatment
Arrhythmias Device: EnSite Precision

Detailed Description:

This is an acute, multi-center, observational, prospective feasibility study with up to 80 patients at up to 5 centers in Europe.

Data will be simultaneously collected on both the EnSite Precision 2.0.1 and VRP mapping systems for the entire duration of the EP mapping and ablation procedure. This study will not require significant change to the current clinical workflow of the mapping and ablation procedure. The VRP operator will observe both displays in real-time and will enter extensive electronic annotations to the VRP data stream to facilitate retrospective analysis. Examples of annotations include drug administration, patient movement, and the introduction of devices such as an intracardiac Echography (ICE) catheter which are not visible on the EnSite mapping system.

If/when the VRP operator notices events which might be better understood with additional data, he/she might ask the physician to hold a catheter in a stable position for an extra few seconds and/or move the catheter to another position. Examples of such events include catheters appearing outside the 3D model and unrealistic catheter shapes on either display. Compliance with such requests is optional and subject to physician preference.

Retrospective data analysis will focus on characterization of the following:

  • Occurence rates and potential causes for Shift and Drift.
  • Frequency and severity of discrepancies between impedance and magnetic coordinates.
  • Positions of catheters relative to the 3D model.
  • Positions of catheters relative to each other, comparing to fluoroscopic images when available.
  • Shapes of catheters on the research system as the catheters are moved to different locations.
  • Final geometry apprearance on the VRP.
  • Voltage and timing maps appearance on the VRP.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: EnSite Precision 2.1 Feasibility Study
Actual Study Start Date : January 4, 2017
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019

Intervention Details:
  • Device: EnSite Precision
    Ablation procedure

Primary Outcome Measures :
  1. Demonstrate feasibility of new algorithms witihn the EnSite Velocity Research Platform (VRP) by assessing the frequency of shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1. [ Time Frame: Up to 12 months ]
    Demonstrate feasibility of new algorithms within the EnSite Velocity Research Platform (VRP) by assessing the frequency of shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient undergoing a cardiac EP mapping and ablation procedure in which a SJM sensor-enabled catheter and the EnSite Precision Cardiac Mapping system is used, is considered eligible for enrollment.

Inclusion Criteria:

  • Patients indicated for a cardiac EP study and ablation procedure using a 3D mapping system.
  • Over 18 years of age
  • Ability to provide informed consent for study participation and be willing and able to comply with the protocol described evaluations.

Exclusion Criteria:

  • Pregnant or possibly pregnant patients
Additional Information:

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Responsible Party: Abbott Medical Devices Identifier: NCT03110146    
Other Study ID Numbers: SJM-CIP-10173
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes