Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population
Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population
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.
This study is a randomized, single-blind, prospective, multi-center post market evaluation.
 Subjects will be screened for study eligibility and asked to complete written informed
 consent prior to any study specific testing assessments. After completing written informed
 consent, a total of 386 subjects will be randomized on a 1:1 basis to receive VT ablation
 treatment using either the Niobe ES or standard manual catheter ablation treatment using
 commercially available products. This will be the largest randomized VT study comparing
 outcomes from RMN to manually guided catheter ablation procedures. Subjects will be
 randomized according to a computer-generated randomization scheme. Randomization will be
 blocked at the study site level and subjects will be blinded to group assignment. Since
 quality of life measurements will be collected during follow-up, this study is single-blinded
 in order to mitigate patient bias. Clinical evaluations will not be masked to the treating
 physician.
Inclusion Criteria:

 -  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%

 Exclusion Criteria:

 -  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