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

Stopped early · Not applicable

Conditions studied: Tachycardia, Ventricular

In brief

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.

Key facts

Study ID

NCT02637947

Run by

Stereotaxis

People needed

182

Starts

2016-01-01

Expected to finish

2022-02-15

Last updated by the study team

2022-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• subject has had an ICD previously implanted
• subject has drug-refractory monomorphic VT
• subject is a candidate for ischemic VT RF ablation
• subject has had a myocardial infarction
• subject has a LVEF less than or equal to 35%

You may not qualify if…

• subject has non-ischemic VT
• subject has a history of stroke within 1 month prior to enrollment
• subject has had an acute myocardial infarction within 30 days prior to enrollment
• subject has unstable angina
• subject has undergone cardiac surgery within 60 days prior to enrollment
• subject is pregnant or nursing
• subject has a limited life expectancy of 1 year or less (Subjects requiring LVAD/IABP intraprocedural support may be enrolled as long as life expectancy is at least 1 year following the ablation procedure.)
• subject is unable or unwilling to cooperate with study procedures
• subject has a known presence of intracardiac thrombi as determined by echocardiography
• subject has a major contraindication to anticoagulation therapy or coagulation disorder
• subject has had a previous pericarditis or cardiac tumor
• subject has had previous thoracic radiation therapy
• any other reason the investigator considers the subject ineligible

Where it is running

• Florida Hospital — Orlando, Florida, United States
• Augusta University — Augusta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Weill Cornell Medical — New York, New York, United States
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States
• Intermountain Heart Institute — Murray, Utah, United States
• Westmead Hospital — Westmead, New South Wales, Australia
• AZ Sint-Jan — Bruges, West Flanders, Belgium
• ZNA Middelheim — Antwerp, Belgium
• Na Homolce Hospital — Prague, Czechia
• Rigshospitalet — Copenhagen, Denmark
• Chu De Nancy - Hôpitaux De Brabois — Nancy, France
• Onze Lieve Vrouwe Gasthuis (OLVG) — Amsterdam, Netherlands
• Erasmus Medical Center — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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