Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population (MAGNETIC-VT Trial)
Recruiting in Palo Alto (17 mi)
+15 other locations
Overseen ByAndrea Natale, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Stereotaxis
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Magnetic navigationExperimental Treatment1 Intervention
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.
Group II: Manual navigationActive Control1 Intervention
Catheter ablation using manual navigation for ventricular tachycardia via a manually navigated Thermocool catheter, or equivalent catheter.
Catheter Ablation is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Pulmonary Vein Isolation (PVI) for:
- Symptomatic paroxysmal or persistent atrial fibrillation
- Heart failure with reduced left ventricular fraction
🇺🇸 Approved in United States as Pulmonary Vein Isolation (PVI) for:
- Symptomatic paroxysmal or persistent atrial fibrillation
- Heart failure with reduced left ventricular fraction
🇨🇦 Approved in Canada as Pulmonary Vein Isolation (PVI) for:
- Symptomatic paroxysmal or persistent atrial fibrillation
- Heart failure with reduced left ventricular fraction
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Intermountain Heart InstituteMurray, UT
Florida HospitalOrlando, FL
Augusta UniversityAugusta, GA
Advocate Christ Medical CenterOak Lawn, IL
More Trial Locations
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Who is running the clinical trial?
StereotaxisLead Sponsor