Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population (MAGNETIC-VT)
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ClinicalTrials.gov Identifier: NCT02637947 |
Recruitment Status :
Terminated
(In the post-market environment, the RCT design did not allow achievement of enrollment goals)
First Posted : December 22, 2015
Last Update Posted : September 27, 2022
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Condition or disease | Intervention/treatment | Phase |
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Tachycardia, Ventricular | Device: catheter ablation using magnetic navigation Device: catheter ablation using manual navigation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 182 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | January 2016 |
Actual Primary Completion Date : | February 15, 2022 |
Actual Study Completion Date : | February 15, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Device: 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. |
Active Comparator: Manual navigation
Catheter ablation using manual navigation for ventricular tachycardia via a manually navigated Thermocool catheter, or equivalent catheter.
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Device: 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. |
- freedom from any VT in the overall cohort [ Time Frame: 12 months ]
- acute success of procedure [ Time Frame: at end of procedure (immediate) ]non-inducibility of clinical VT and/or other monomorphic VT using typical stimulation protocol for induction
- freedom from VT in large scar subpopulation [ Time Frame: 12 months ]
- major adverse events [ Time Frame: 48 hours post-procedure ]death, cardiac tamponade, stroke, bleeding requiring surgical intervention, progressive heart failure related to VT/VF recurrence
- mortality rate [ Time Frame: 12 months ]
- Total number of appropriate ICD defibrillator shocks [ Time Frame: 12 months ]
- Total number of ICD applications of anti-tachycardia pacing [ Time Frame: 12 months ]
- Total procedure time (skin to skin) [ Time Frame: through end of acute procedure, an average of 3 hours ]
- Total fluoroscopy time [ Time Frame: through end of acute procedure, an average of 3 hours ]
- Total fluoroscopy dose [ Time Frame: through end of acute procedure, an average of 3 hours ]
- Total mapping time [ Time Frame: through end of acute procedure, an average of 3 hours ]
- Total ablation time [ Time Frame: through end of acute procedure, an average of 3 hours ]
- Total mapping points prior to ablation [ Time Frame: through end of acute procedure, an average of 3 hours ]
- Total ablation energy delivery [ Time Frame: through end of acute procedure, an average of 3 hours ]Watts X seconds / Total scar surface area
- Patient quality of life (SF-12) [ Time Frame: 12 months ]Medical Outcomes Study 12-item Short-Form Health Survey

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637947
United States, Florida | |
Florida Hospital | |
Orlando, Florida, United States, 32803 | |
United States, Georgia | |
Augusta University | |
Augusta, Georgia, United States, 30912 | |
United States, Illinois | |
University of Chicago Medical Center | |
Chicago, Illinois, United States, 60637 | |
Advocate Christ Medical Center | |
Oak Lawn, Illinois, United States, 60453 | |
United States, Kansas | |
The University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 | |
United States, New York | |
Weill Cornell Medical | |
New York, New York, United States, 10065 | |
United States, Texas | |
Texas Cardiac Arrhythmia Research Foundation | |
Austin, Texas, United States, 78705 | |
United States, Utah | |
Intermountain Heart Institute | |
Murray, Utah, United States, 84107 | |
Australia, New South Wales | |
Westmead Hospital | |
Westmead, New South Wales, Australia, 2145 | |
Belgium | |
AZ Sint-Jan | |
Brugge, West Flanders, Belgium, 8000 | |
ZNA Middelheim | |
Antwerpen, Belgium | |
Czechia | |
Na Homolce Hospital | |
Praha, Czechia, 15030 | |
Denmark | |
Rigshospitalet | |
Copenhagen, Denmark | |
France | |
Chu De Nancy - Hôpitaux De Brabois | |
Nancy, France | |
Netherlands | |
Onze Lieve Vrouwe Gasthuis (OLVG) | |
Amsterdam, Netherlands | |
Erasmus Medical Center | |
Rotterdam, Netherlands |
Principal Investigator: | Andrea Natale, MD | Texas Cardiac Arrhythmia Research Foundation |
Responsible Party: | Stereotaxis |
ClinicalTrials.gov Identifier: | NCT02637947 |
Other Study ID Numbers: |
CLIN-021 |
First Posted: | December 22, 2015 Key Record Dates |
Last Update Posted: | September 27, 2022 |
Last Verified: | September 2022 |
Tachycardia Tachycardia, Ventricular Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Cardiac Conduction System Disease Pathologic Processes |