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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

L. Di Biase, R. Tung, T. Szili-Torok, JD. Burkhardt, P. Weiss, R. Tavernier, AE. Berman, E. Wissner, W. Spear, X. Chen, P. Neužil, J. Skoda, D. Lakkireddy, B. Schwagten, K. Lock, A. Natale, . ,

. 2017 ; 48 (3) : 237-245. [pub] 20170107

Language English Country Netherlands

Document type Journal Article, Multicenter Study, Randomized Controlled Trial

Persistent link   https://www.medvik.cz/link/bmc18016817
E-resources Online Full text

NLK ProQuest Central from 1997-07-01 to 1 year ago
Medline Complete (EBSCOhost) from 2011-01-01 to 1 year ago
Health & Medicine (ProQuest) from 1997-07-01 to 1 year ago

Links

PubMed 28064433
DOI 10.1007/s10840-016-0217-3
Knihovny.cz E-resources

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.

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