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

on behalf of MAGNETIC VT investigators

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)237-245
Number of pages9
JournalJournal of Interventional Cardiac Electrophysiology
Volume48
Issue number3
DOIs
StatePublished - Apr 1 2017

Fingerprint

Ventricular Tachycardia
Stroke Volume
Randomized Controlled Trials
Prospective Studies
Population
Cicatrix
Implantable Defibrillators
Cardiomyopathies
Tachycardia
Electrodes
Catheters
Recurrence
Mortality
Therapeutics

Keywords

  • Atrial fibrillation
  • Catheter ablation
  • Heart failure
  • Ischemic cardiomyopathy
  • Robotic magnetic navigation
  • Ventricular tachycardia

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

@article{aacc48688a5d43e08a086e011e146b38,
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 = "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.",
keywords = "Atrial fibrillation, Catheter ablation, Heart failure, Ischemic cardiomyopathy, Robotic magnetic navigation, Ventricular tachycardia",
author = "{on behalf of MAGNETIC VT investigators} and {Di Biase}, Luigi and Roderick Tung and Tam{\'a}s Szili-Torok and Burkhardt, {J. David} and Peter Weiss and Rene Tavernier and Berman, {Adam E.} and Berman, {Adam Eric} and William Spear and Xu Chen and Petr Neužil and Jan Skoda and Dhanunjaya Lakkireddy and Bruno Schwagten and Ken Lock and Andrea Natale",
year = "2017",
month = "4",
day = "1",
doi = "10.1007/s10840-016-0217-3",
language = "English (US)",
volume = "48",
pages = "237--245",
journal = "Journal of Interventional Cardiac Electrophysiology",
issn = "1383-875X",
publisher = "Springer Netherlands",
number = "3",

}

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 - Berman, Adam Eric

AU - Spear, William

AU - Chen, Xu

AU - Neužil, Petr

AU - Skoda, Jan

AU - Lakkireddy, Dhanunjaya

AU - Schwagten, Bruno

AU - Lock, Ken

AU - Natale, Andrea

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

UR - http://www.scopus.com/inward/record.url?scp=85008449981&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85008449981&partnerID=8YFLogxK

U2 - 10.1007/s10840-016-0217-3

DO - 10.1007/s10840-016-0217-3

M3 - Article

VL - 48

SP - 237

EP - 245

JO - Journal of Interventional Cardiac Electrophysiology

JF - Journal of Interventional Cardiac Electrophysiology

SN - 1383-875X

IS - 3

ER -