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

  • STATUS
    Recruiting
  • End date
    Dec 24, 2022
  • participants needed
    386
  • sponsor
    Stereotaxis
Updated on 24 January 2021
ejection fraction
myocardial infarction
infarct
scar
catheter ablation

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.

Description

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.

Details
Condition Ventricular tachycardia
Treatment catheter ablation using magnetic navigation, catheter ablation using manual navigation
Clinical Study IdentifierNCT02637947
SponsorStereotaxis
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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