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

• Published in: Journal of interventional cardiac electrophysiology Vol. 48; no. 3; pp. 237 - 245
• Main Authors: Di Biase, Luigi, Tung, Roderick, Szili-Torok, Tamás, Burkhardt, J. David, Weiss, Peter, Tavernier, Rene, Berman, Adam E., Wissner, Erik, Spear, William, Chen, Xu, Neužil, Petr, Skoda, Jan, Lakkireddy, Dhanunjaya, Schwagten, Bruno, Lock, Ken, Natale, Andrea
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.04.2017; Springer Nature B.V
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Body Surface Potential Mapping - methods; Cardiology; Catheter Ablation - methods; Female; Humans; Magnetics; Male; Medicine; Medicine & Public Health; Middle Aged; Single-Blind Method; Stroke Volume; Tachycardia, Ventricular - complications; Tachycardia, Ventricular - diagnostic imaging; Tachycardia, Ventricular - surgery; Treatment Outcome; United States; Ventricular Dysfunction, Left - diagnostic imaging; Ventricular Dysfunction, Left - etiology; Ventricular Dysfunction, Left - prevention & control; Young Adult; Heart failure; Ventricular tachycardia; Robotic magnetic navigation; Atrial fibrillation; Catheter ablation; Ischemic cardiomyopathy
• ISSN: 1383-875X; 1572-8595; 1572-8595
• DOI: 10.1007/s10840-016-0217-3

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