A Prospective, Multi-center, Post Market Randomized Controlled Trial Comparing VT Ablation Outcomes Using Remote MAGNETIC Navigation Guided Substrate Mapping and Ablation Versus Manual Approach in a Low LVEF Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Stereotaxis
- Enrollment
- 182
- Locations
- 16
- Primary Endpoint
- freedom from any VT in the overall cohort
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Magnetic navigation
Catheter ablation using magnetic navigation for ventricular tachycardia via remote magnetic navigation of a NaviStar RMT ThermoCool catheter, or other magnetically compatible catheter, via Stereotaxis's Niobe ES system.
Intervention: catheter ablation using magnetic navigation (Device)
Manual navigation
Catheter ablation using manual navigation for ventricular tachycardia via a manually navigated Thermocool catheter, or equivalent catheter.
Intervention: catheter ablation using manual navigation (Device)
Outcomes
Primary Outcomes
freedom from any VT in the overall cohort
Time Frame: 12 months
Secondary Outcomes
- mortality rate(12 months)
- acute success of procedure(at end of procedure (immediate))
- freedom from VT in large scar subpopulation(12 months)
- major adverse events(48 hours post-procedure)