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

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

Jazyk angličtina Země Nizozemsko Médium print-electronic

Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie

Perzistentní odkaz   https://www.medvik.cz/link/pmid28064433
Odkazy

PubMed 28064433
DOI 10.1007/s10840-016-0217-3
PII: 10.1007/s10840-016-0217-3
Knihovny.cz E-zdroje

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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N Engl J Med. 2016 Jul 14;375(2):111-21 PubMed

J Cardiovasc Electrophysiol. 2015 Jul 20;:null PubMed

Biometrics. 1979 Sep;35(3):549-56 PubMed

J Am Coll Cardiol. 2002 Jan 16;39(2):210-8 PubMed

Circulation. 2002 Jan 29;105(4):539-42 PubMed

Lancet. 2010 Jan 2;375(9708):31-40 PubMed

Heart Rhythm. 2010 Aug;7(8):1029-35 PubMed

J Am Coll Cardiol. 2012 Jul 10;60(2):132-41 PubMed

J Interv Card Electrophysiol. 2015 Oct;44(1):1-8 PubMed

N Engl J Med. 2007 Dec 27;357(26):2657-65 PubMed

Europace. 2011 Jul;13(7):1015-21 PubMed

J Am Coll Cardiol. 2010 May 25;55(21):2355-65 PubMed

J Cardiovasc Electrophysiol. 2012 Sep;23(9):948-54 PubMed

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ClinicalTrials.gov
NCT02637947

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