title: 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.
abstract: OBJECTIVE
  Patients with ischemic cardiomyopathy (ICM) are prone to scar-related ventricular tachycardia (VT). The success of VT ablation depends on accurate arrhythmogenic substrate localization, followed by optimal delivery of energy provided by constant electrode-tissue contact. Current manual and remote magnetic navigation (RMN)-guided ablation strategies aim to identify a reentry circuit and to target a critical isthmus through activation and entrainment mapping during ongoing tachycardia. The MAGNETIC VT trial will assess if VT ablation using the Niobe™ ES magnetic navigation system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT and low ejection fraction.
  
  
  RESULTS
  This is a randomized, single-blind, prospective, multicenter post-market study. A total of 386 subjects (193 per group) will be enrolled and randomized 1:1 between treatment with the Niobe ES system and treatment via a manual procedure at up to 20 sites. The study population will consist of patients with ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) of ≤35% and implantable cardioverter defibrillator (ICD) who have sustained monomorphic VT. The primary study endpoint is freedom from any recurrence of VT through 12 months. The secondary endpoints are acute success; freedom from any VT at 1 year in a large-scar subpopulation; procedure-related major adverse events; and mortality rate through 12-month follow-up. Follow-up will consist of visits at 3, 6, 9, and 12 months, all of which will include ICD interrogation.
  
  
  CONCLUSIONS
  The MAGNETIC VT trial will help determine whether substrate-based ablation of VT with RMN has clinical advantages over manual catheter manipulation.
  
  
  BACKGROUND
  Clinicaltrials.gov identifier: NCT02637947.
authors.affiliation: Texas Cardiac Arrhythmia Institute at St. David's Medical Center, 3000 N. I-35, Suite 720, Austin, TX, 78705, USA.|Albert Einstein College of Medicine, at Montefiore Hospital, New York, NY, USA.|Department of Biomedical Engineering, University of Texas, Austin, TX, USA.|Department of Cardiology, University of Foggia, Foggia, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Di Biase
authors.affiliation: Pritzker School of Medicine, University of Chicago Medicine, Chicago, IL, USA.
authors.forename: Roderick
authors.initials: R
authors.lastname: Tung
authors.affiliation: Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Tamás
authors.initials: T
authors.lastname: Szili-Torok
authors.affiliation: Texas Cardiac Arrhythmia Institute at St. David's Medical Center, 3000 N. I-35, Suite 720, Austin, TX, 78705, USA.
authors.forename: J David
authors.initials: JD
authors.lastname: Burkhardt
authors.affiliation: Intermountain Medical Center, Murray, UT, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Weiss
authors.affiliation: Az Sint-Jan Brugge, Brugge, Belgium.
authors.forename: Rene
authors.initials: R
authors.lastname: Tavernier
authors.affiliation: Medical College of Georgia, Augusta University, Augusta, GA, USA.
authors.forename: Adam E
authors.initials: AE
authors.lastname: Berman
authors.affiliation: Advocate Christ Medical Center, Chicago, IL, USA.
authors.forename: Erik
authors.initials: E
authors.lastname: Wissner
authors.affiliation: Advocate Christ Medical Center, Chicago, IL, USA.
authors.forename: William
authors.initials: W
authors.lastname: Spear
authors.affiliation: Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Xu
authors.initials: X
authors.lastname: Chen
authors.affiliation: Department of Cardiology, Nemocnice Na Homolce Hospital, Prague, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Neužil
authors.affiliation: Department of Cardiology, Nemocnice Na Homolce Hospital, Prague, Czech Republic.
authors.forename: Jan
authors.initials: J
authors.lastname: Skoda
authors.affiliation: University of Kansas, Kansas City, MO, USA.
authors.forename: Dhanunjaya
authors.initials: D
authors.lastname: Lakkireddy
authors.affiliation: ZNA Middelheim, Antwerp, Belgium.
authors.forename: Bruno
authors.initials: B
authors.lastname: Schwagten
authors.affiliation: Stereotaxis, Inc., St. Louis, MO, USA.
authors.forename: Ken
authors.initials: K
authors.lastname: Lock
authors.affiliation: Texas Cardiac Arrhythmia Institute at St. David's Medical Center, 3000 N. I-35, Suite 720, Austin, TX, 78705, USA. dr.natale@gmail.com.|Department of Biomedical Engineering, University of Texas, Austin, TX, USA. dr.natale@gmail.com.|California Pacific Medical Center, San Francisco, CA, USA. dr.natale@gmail.com.|Division of Cardiology, Stanford University, Palo Alto, CA, USA. dr.natale@gmail.com.|Case Western Reserve University, Cleveland, OH, USA. dr.natale@gmail.com.|Scripps Clinic, San Diego, CA, USA. dr.natale@gmail.com.|Dell Medical School, Austin, TX, USA. dr.natale@gmail.com.
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018780:Body Surface Potential Mapping / Q000379:methods*; D017115:Catheter Ablation / Q000379:methods*; D005260:Female; D006801:Humans; D008280:Magnetics; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D013318:Stroke Volume; D017180:Tachycardia, Ventricular / Q000150:complications / Q000000981:diagnostic imaging* / Q000601:surgery*; D016896:Treatment Outcome; D014481:United States; D018487:Ventricular Dysfunction, Left / Q000000981:diagnostic imaging* / Q000209:etiology / Q000517:prevention & control*; D055815:Young Adult
keywords: Atrial fibrillation; Catheter ablation; Heart failure; Ischemic cardiomyopathy; Robotic magnetic navigation; Ventricular tachycardia