دورية أكاديمية
أعرض في EDS

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.

التفاصيل البيبلوغرافية
العنوان: 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.
المؤلفون: Di Biase L; Texas Cardiac Arrhythmia Institute at St. David's Medical Center, 3000 N. I-35, Suite 720, Austin, TX, 78705, USA.; Albert Einstein College of Medicine, at Montefiore Hospital, New York, NY, USA.; Department of Biomedical Engineering, University of Texas, Austin, TX, USA.; Department of Cardiology, University of Foggia, Foggia, Italy., Tung R; Pritzker School of Medicine, University of Chicago Medicine, Chicago, IL, USA., Szili-Torok T; Erasmus Medical Center, Rotterdam, The Netherlands., Burkhardt JD; Texas Cardiac Arrhythmia Institute at St. David's Medical Center, 3000 N. I-35, Suite 720, Austin, TX, 78705, USA., Weiss P; Intermountain Medical Center, Murray, UT, USA., Tavernier R; Az Sint-Jan Brugge, Brugge, Belgium., Berman AE; Medical College of Georgia, Augusta University, Augusta, GA, USA., Wissner E; Advocate Christ Medical Center, Chicago, IL, USA., Spear W; Advocate Christ Medical Center, Chicago, IL, USA., Chen X; Department of Cardiology, Rigshospitalet, Copenhagen, Denmark., Neužil P; Department of Cardiology, Nemocnice Na Homolce Hospital, Prague, Czech Republic., Skoda J; Department of Cardiology, Nemocnice Na Homolce Hospital, Prague, Czech Republic., Lakkireddy D; University of Kansas, Kansas City, MO, USA., Schwagten B; ZNA Middelheim, Antwerp, Belgium., Lock K; Stereotaxis, Inc., St. Louis, MO, USA., Natale A; Texas Cardiac Arrhythmia Institute at St. David's Medical Center, 3000 N. I-35, Suite 720, Austin, TX, 78705, USA. dr.natale@gmail.com.; Department of Biomedical Engineering, University of Texas, Austin, TX, USA. dr.natale@gmail.com.; California Pacific Medical Center, San Francisco, CA, USA. dr.natale@gmail.com.; Division of Cardiology, Stanford University, Palo Alto, CA, USA. dr.natale@gmail.com.; Case Western Reserve University, Cleveland, OH, USA. dr.natale@gmail.com.; Scripps Clinic, San Diego, CA, USA. dr.natale@gmail.com.; Dell Medical School, Austin, TX, USA. dr.natale@gmail.com.
مؤلفون مشاركون: MAGNETIC VT investigators
المصدر: Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing [J Interv Card Electrophysiol] 2017 Apr; Vol. 48 (3), pp. 237-245. Date of Electronic Publication: 2017 Jan 07.
نوع المنشور: Journal Article; Multicenter Study; Randomized Controlled Trial
اللغة: English
بيانات الدورية: Publisher: Springer Country of Publication: Netherlands NLM ID: 9708966 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1572-8595 (Electronic) Linking ISSN: 1383875X NLM ISO Abbreviation: J Interv Card Electrophysiol Subsets: MEDLINE
أسماء مطبوعة: Publication: Amsterdam : Springer
Original Publication: Norwell, MA : Kluwer Academic Publishers, c1997-
مواضيع طبية MeSH: Body Surface Potential Mapping/*methods , Catheter Ablation/*methods , Tachycardia, Ventricular/*diagnostic imaging , Tachycardia, Ventricular/*surgery , Ventricular Dysfunction, Left/*diagnostic imaging , Ventricular Dysfunction, Left/*prevention & control, Adolescent ; Adult ; Aged ; Aged, 80 and over ; Female ; Humans ; Magnetics ; Male ; Middle Aged ; Single-Blind Method ; Stroke Volume ; Tachycardia, Ventricular/complications ; Treatment Outcome ; United States ; Ventricular Dysfunction, Left/etiology ; Young Adult
مستخلص: 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.
References: Heart Rhythm. 2013 Aug;10(8):1178-83. (PMID: 23692891)
N Engl J Med. 2016 Jul 14;375(2):111-21. (PMID: 27149033)
J Cardiovasc Electrophysiol. 2015 Jul 20;:null. (PMID: 26200478)
Biometrics. 1979 Sep;35(3):549-56. (PMID: 497341)
J Am Coll Cardiol. 2002 Jan 16;39(2):210-8. (PMID: 11788209)
Circulation. 2002 Jan 29;105(4):539-42. (PMID: 11815441)
Lancet. 2010 Jan 2;375(9708):31-40. (PMID: 20109864)
Heart Rhythm. 2010 Aug;7(8):1029-35. (PMID: 20434589)
J Am Coll Cardiol. 2012 Jul 10;60(2):132-41. (PMID: 22766340)
J Interv Card Electrophysiol. 2015 Oct;44(1):1-8. (PMID: 26123094)
N Engl J Med. 2007 Dec 27;357(26):2657-65. (PMID: 18160685)
Europace. 2011 Jul;13(7):1015-21. (PMID: 21508006)
J Am Coll Cardiol. 2010 May 25;55(21):2355-65. (PMID: 20488307)
J Cardiovasc Electrophysiol. 2012 Sep;23(9):948-54. (PMID: 22554147)
فهرسة مساهمة: Keywords: Atrial fibrillation; Catheter ablation; Heart failure; Ischemic cardiomyopathy; Robotic magnetic navigation; Ventricular tachycardia
سلسلة جزيئية: ClinicalTrials.gov NCT02637947
تواريخ الأحداث: Date Created: 20170109 Date Completed: 20171113 Latest Revision: 20181113
رمز التحديث: 20231215
DOI: 10.1007/s10840-016-0217-3
PMID: 28064433
قاعدة البيانات: MEDLINE
الوصف
تدمد:1572-8595
DOI:10.1007/s10840-016-0217-3