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Trial record 2 of 18 for:    abbott ensite

EnSite Precision 2.1 Feasibility Study

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ClinicalTrials.gov Identifier: NCT03110146
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date February 2, 2017
First Posted Date April 12, 2017
Last Update Posted Date February 12, 2019
Actual Study Start Date January 4, 2017
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 6, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title EnSite Precision 2.1 Feasibility Study
Official Title EnSite Precision 2.1 Feasibility Study
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.

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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
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.
Condition Arrhythmias
Intervention Device: EnSite Precision
Ablation procedure
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 6, 2017)
80
Original Actual Enrollment Same as current
Actual Study Completion Date February 1, 2019
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03110146
Other Study ID Numbers SJM-CIP-10173
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators Not Provided
PRS Account Abbott Medical Devices
Verification Date February 2019