Study Stopped
In the post-market environment, the RCT design did not allow achievement of enrollment goals
Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population
MAGNETIC-VT
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
1 other identifier
interventional
182
7 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2015
CompletedFirst Posted
Study publicly available on registry
December 22, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2022
CompletedSeptember 27, 2022
September 1, 2022
6.1 years
December 4, 2015
September 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
freedom from any VT in the overall cohort
12 months
Secondary Outcomes (4)
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
mortality rate
12 months
Other Outcomes (10)
Total number of appropriate ICD defibrillator shocks
12 months
Total number of ICD applications of anti-tachycardia pacing
12 months
Total procedure time (skin to skin)
through end of acute procedure, an average of 3 hours
- +7 more other outcomes
Study Arms (2)
Magnetic navigation
EXPERIMENTALCatheter 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.
Manual navigation
ACTIVE COMPARATORCatheter ablation using manual navigation for ventricular tachycardia via a manually navigated Thermocool catheter, or equivalent catheter.
Interventions
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.
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
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stereotaxislead
Study Sites (16)
Florida Hospital
Orlando, Florida, 32803, United States
Augusta University
Augusta, Georgia, 30912, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Weill Cornell Medical
New York, New York, 10065, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
Intermountain Heart Institute
Murray, Utah, 84107, United States
Westmead Hospital
Westmead, New South Wales, 2145, Australia
AZ Sint-Jan
Bruges, West Flanders, 8000, Belgium
ZNA Middelheim
Antwerp, Belgium
Na Homolce Hospital
Prague, 15030, Czechia
Rigshospitalet
Copenhagen, Denmark
Chu De Nancy - Hôpitaux De Brabois
Nancy, France
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Related Publications (1)
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.
PMID: 28064433DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Natale, MD
Texas Cardiac Arrhythmia Research Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2015
First Posted
December 22, 2015
Study Start
January 1, 2016
Primary Completion
February 15, 2022
Study Completion
February 15, 2022
Last Updated
September 27, 2022
Record last verified: 2022-09