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

Luigi Di Biase, Roderick Tung, Tamás Szili-Torok, J. David Burkhardt, Peter Weiss, Rene Tavernier, Adam E. Berman, Erik Wissner, William Spear, Xu Chen, Petr Neužil, Jan Skoda, Dhanunjaya Lakkireddy, Bruno Schwagten, Ken Lock, Andrea Natale, Behalf Of Magnetic Vt Investigators On Behalf Of Magnetic Vt Investigators

Research output: Contribution to journalArticle

4 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)1-9
Number of pages9
JournalJournal of Interventional Cardiac Electrophysiology
DOIs
StateAccepted/In press - Jan 7 2017

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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

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. / 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; On Behalf Of Magnetic Vt Investigators, Behalf Of Magnetic Vt Investigators.

In: Journal of Interventional Cardiac Electrophysiology, 07.01.2017, p. 1-9.

Research output: Contribution to journalArticle

Di Biase, L, Tung, R, Szili-Torok, T, Burkhardt, JD, Weiss, P, Tavernier, R, Berman, AE, Wissner, E, Spear, W, Chen, X, Neužil, P, Skoda, J, Lakkireddy, D, Schwagten, B, Lock, K, Natale, A & On Behalf Of Magnetic Vt Investigators, BOMVI 2017, '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', Journal of Interventional Cardiac Electrophysiology, pp. 1-9. https://doi.org/10.1007/s10840-016-0217-3
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 ; On Behalf Of Magnetic Vt Investigators, Behalf Of Magnetic Vt Investigators. / 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. In: Journal of Interventional Cardiac Electrophysiology. 2017 ; pp. 1-9.
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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",
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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 - 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

AU - On Behalf Of Magnetic Vt Investigators, Behalf Of Magnetic Vt Investigators

PY - 2017/1/7

Y1 - 2017/1/7

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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