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Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population

NCT02637947 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2022-09-27

No results posted yet for this study

Summary

The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction population.

Conditions

  • Tachycardia, Ventricular

Interventions

DEVICE

catheter ablation using magnetic navigation

elimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of Stereotaxis's Niobe ES System with the NaviStar RMT ThermoCool catheter or other magnetically compatible catheters.

DEVICE

catheter ablation using manual navigation

elimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of the NaviStar ThermoCool catheter or other manually navigated catheters.

Sponsors & Collaborators

  • Stereotaxis

    lead INDUSTRY

Principal Investigators

  • Andrea Natale, MD · Texas Cardiac Arrhythmia Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2022-02-15
Completion
2022-02-15

Countries

  • United States
  • Australia
  • Belgium
  • Czechia
  • Denmark
  • France
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02637947 on ClinicalTrials.gov