Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population
NCT ID: NCT02637947
Last Updated: 2022-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
182 participants
INTERVENTIONAL
2016-01-31
2022-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
catheter ablation using magnetic navigation
elimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of Stereotaxis's Niobe ES System with the NaviStar RMT ThermoCool catheter or other magnetically compatible catheters.
Manual navigation
Catheter ablation using manual navigation for ventricular tachycardia via a manually navigated Thermocool catheter, or equivalent catheter.
catheter ablation using manual navigation
elimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of the NaviStar ThermoCool catheter or other manually navigated catheters.
Interventions
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catheter ablation using magnetic navigation
elimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of Stereotaxis's Niobe ES System with the NaviStar RMT ThermoCool catheter or other magnetically compatible catheters.
catheter ablation using manual navigation
elimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of the NaviStar ThermoCool catheter or other manually navigated catheters.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Stereotaxis
INDUSTRY
Responsible Party
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Principal Investigators
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Andrea Natale, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Cardiac Arrhythmia Research Foundation
Locations
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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
Countries
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References
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Di Biase L, Tung R, Szili-Torok T, Burkhardt JD, Weiss P, Tavernier R, Berman AE, Wissner E, Spear W, Chen X, Neuzil P, Skoda J, Lakkireddy D, Schwagten B, Lock K, Natale A; MAGNETIC VT investigators. MAGNETIC VT study: a prospective, multicenter, 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. J Interv Card Electrophysiol. 2017 Apr;48(3):237-245. doi: 10.1007/s10840-016-0217-3. Epub 2017 Jan 7.
Other Identifiers
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CLIN-021
Identifier Type: -
Identifier Source: org_study_id
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