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Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population (MAGNETIC-VT)

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ClinicalTrials.gov Identifier: NCT02637947
Recruitment Status : Recruiting
First Posted : December 22, 2015
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Stereotaxis

Tracking Information
First Submitted Date  ICMJE December 4, 2015
First Posted Date  ICMJE December 22, 2015
Last Update Posted Date March 17, 2020
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
freedom from any VT in the overall cohort [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 17, 2015)
freedom from recurrence of VT [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2015)
  • acute success of procedure [ Time Frame: at end of procedure (immediate) ]
    non-inducibility of clinical VT and/or other monomorphic VT using typical stimulation protocol for induction
  • freedom from VT in large scar subpopulation [ Time Frame: 12 months ]
  • major adverse events [ Time Frame: 48 hours post-procedure ]
    death, cardiac tamponade, stroke, bleeding requiring surgical intervention, progressive heart failure related to VT/VF recurrence
  • mortality rate [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 5, 2018)
  • Total number of appropriate ICD defibrillator shocks [ Time Frame: 12 months ]
  • Total number of ICD applications of anti-tachycardia pacing [ Time Frame: 12 months ]
  • Total procedure time (skin to skin) [ Time Frame: through end of acute procedure, an average of 3 hours ]
  • Total fluoroscopy time [ Time Frame: through end of acute procedure, an average of 3 hours ]
  • Total fluoroscopy dose [ Time Frame: through end of acute procedure, an average of 3 hours ]
  • Total mapping time [ Time Frame: through end of acute procedure, an average of 3 hours ]
  • Total ablation time [ Time Frame: through end of acute procedure, an average of 3 hours ]
  • Total mapping points prior to ablation [ Time Frame: through end of acute procedure, an average of 3 hours ]
  • Total ablation energy delivery [ Time Frame: through end of acute procedure, an average of 3 hours ]
    Watts X seconds / Total scar surface area
  • Patient quality of life (SF-12) [ Time Frame: 12 months ]
    Medical Outcomes Study 12-item Short-Form Health Survey
Original Other Pre-specified Outcome Measures
 (submitted: December 17, 2015)
  • Total number of appropriate ICD defibrillator shocks [ Time Frame: 12 months ]
  • Total number of ICD applications of anti-tachycardia pacing [ Time Frame: 12 months ]
  • Total procedure time (skin to skin) [ Time Frame: through end of acute procedure, an average of 3 hours ]
  • Total fluoroscopy time [ Time Frame: through end of acute procedure, an average of 3 hours ]
  • Total fluoroscopy dose [ Time Frame: through end of acute procedure, an average of 3 hours ]
  • Total mapping time [ Time Frame: through end of acute procedure, an average of 3 hours ]
  • Total ablation time [ Time Frame: through end of acute procedure, an average of 3 hours ]
  • Total mapping points prior to ablation [ Time Frame: through end of acute procedure, an average of 3 hours ]
  • Total ablation energy delivery [ Time Frame: through end of acute procedure, an average of 3 hours ]
    Watts X seconds / Total scar surface area
  • Length of stay in hospital [ Time Frame: 1 week ]
  • Patient quality of life (SF-12) [ Time Frame: 12 months ]
    Medical Outcomes Study 12-item Short-Form Health Survey
  • Health Outcome Measure (EQ-5D-5L) [ Time Frame: 12 months ]
    standardized measure of health status
 
Descriptive Information
Brief Title  ICMJE Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population
Official Title  ICMJE A Prospective, Multi-center, 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
Brief Summary The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction population.
Detailed Description This study is a randomized, single-blind, prospective, multi-center post market evaluation. Subjects will be screened for study eligibility and asked to complete written informed consent prior to any study specific testing assessments. After completing written informed consent, a total of 386 subjects will be randomized on a 1:1 basis to receive VT ablation treatment using either the Niobe ES or standard manual catheter ablation treatment using commercially available products. This will be the largest randomized VT study comparing outcomes from RMN to manually guided catheter ablation procedures. Subjects will be randomized according to a computer-generated randomization scheme. Randomization will be blocked at the study site level and subjects will be blinded to group assignment. Since quality of life measurements will be collected during follow-up, this study is single-blinded in order to mitigate patient bias. Clinical evaluations will not be masked to the treating physician.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Tachycardia, Ventricular
Intervention  ICMJE
  • Device: catheter ablation using magnetic navigation
    elimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of Stereotaxis's Niobe ES System with the NaviStar RMT ThermoCool catheter or other magnetically compatible catheters.
  • Device: catheter ablation using manual navigation
    elimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of the NaviStar ThermoCool catheter or other manually navigated catheters.
Study Arms  ICMJE
  • Experimental: Magnetic navigation
    Catheter ablation using magnetic navigation for ventricular tachycardia via remote magnetic navigation of a NaviStar RMT ThermoCool catheter, or other magnetically compatible catheter, via Stereotaxis's Niobe ES system.
    Intervention: Device: catheter ablation using magnetic navigation
  • Active Comparator: Manual navigation
    Catheter ablation using manual navigation for ventricular tachycardia via a manually navigated Thermocool catheter, or equivalent catheter.
    Intervention: Device: catheter ablation using manual navigation
Publications * 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; 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. J Interv Card Electrophysiol. 2017 Apr;48(3):237-245. doi: 10.1007/s10840-016-0217-3. Epub 2017 Jan 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 17, 2016)
386
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2015)
382
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • subject has had an ICD previously implanted
  • subject has drug-refractory monomorphic VT
  • subject is a candidate for ischemic VT RF ablation
  • subject has had a myocardial infarction
  • subject has a LVEF less than or equal to 35%

Exclusion Criteria:

  • subject has non-ischemic VT
  • subject has a history of stroke within 1 month prior to enrollment
  • subject has had an acute myocardial infarction within 30 days prior to enrollment
  • subject has unstable angina
  • subject has undergone cardiac surgery within 60 days prior to enrollment
  • subject is pregnant or nursing
  • subject has a limited life expectancy of 1 year or less (Subjects requiring LVAD/IABP intraprocedural support may be enrolled as long as life expectancy is at least 1 year following the ablation procedure.)
  • subject is unable or unwilling to cooperate with study procedures
  • subject has a known presence of intracardiac thrombi as determined by echocardiography
  • subject has a major contraindication to anticoagulation therapy or coagulation disorder
  • subject has had a previous pericarditis or cardiac tumor
  • subject has had previous thoracic radiation therapy
  • any other reason the investigator considers the subject ineligible
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ken Lock 13146786123 ken.lock@stereotaxis.com
Listed Location Countries  ICMJE Australia,   Belgium,   Czechia,   Denmark,   France,   Netherlands,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02637947
Other Study ID Numbers  ICMJE CLIN-021
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stereotaxis
Study Sponsor  ICMJE Stereotaxis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
PRS Account Stereotaxis
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP