TY - JOUR
T1 - MAGNETIC VT study
T2 - 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
AU - on behalf of MAGNETIC VT investigators
AU - Di Biase, Luigi
AU - Tung, Roderick
AU - Szili-Torok, Tamás
AU - Burkhardt, J. David
AU - Weiss, Peter
AU - Tavernier, Rene
AU - Berman, Adam E.
AU - Wissner, Erik
AU - Spear, William
AU - Chen, Xu
AU - Neužil, Petr
AU - Skoda, Jan
AU - Lakkireddy, Dhanunjaya
AU - Schwagten, Bruno
AU - Lock, Ken
AU - Natale, Andrea
N1 - Publisher Copyright:
© 2017, Springer Science+Business Media New York.
PY - 2017/4/1
Y1 - 2017/4/1
N2 - Purpose: 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. Methods and 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. Trial registration: Clinicaltrials.gov identifier: NCT02637947.
AB - Purpose: 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. Methods and 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. Trial registration: Clinicaltrials.gov identifier: NCT02637947.
KW - Atrial fibrillation
KW - Catheter ablation
KW - Heart failure
KW - Ischemic cardiomyopathy
KW - Robotic magnetic navigation
KW - Ventricular tachycardia
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U2 - 10.1007/s10840-016-0217-3
DO - 10.1007/s10840-016-0217-3
M3 - Article
C2 - 28064433
AN - SCOPUS:85008449981
SN - 1383-875X
VL - 48
SP - 237
EP - 245
JO - Journal of Interventional Cardiac Electrophysiology
JF - Journal of Interventional Cardiac Electrophysiology
IS - 3
ER -