NCT03110146

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2017

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

2.1 years

First QC Date

February 2, 2017

Last Update Submit

February 11, 2019

Conditions

Arrhythmias

Outcome Measures

Primary Outcomes (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.

    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

    Up to 12 months

Interventions

EnSite PrecisionDEVICE

Ablation procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant or possibly pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2017

First Posted

April 12, 2017

Study Start

January 4, 2017

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

February 12, 2019

Record last verified: 2019-02