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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 : September 8, 2017
Sponsor:
Information provided by (Responsible Party):

December 4, 2015
December 22, 2015
September 8, 2017
January 2016
December 2019   (Final data collection date for primary outcome measure)
freedom from any VT in the overall cohort [ Time Frame: 12 months ]
freedom from recurrence of VT [ Time Frame: 12 months ]
Complete list of historical versions of study NCT02637947 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
  • 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
Same as current
 
Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population
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
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.
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 382 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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Tachycardia, Ventricular
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
386
December 2019
December 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Ken Lock 13146786123 ken.lock@stereotaxis.com
Australia,   Belgium,   Czechia,   Denmark,   France,   Netherlands,   United States
Czech Republic
 
NCT02637947
CLIN-021
No
Not Provided
Not Provided
Stereotaxis
Stereotaxis
Not Provided
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
Stereotaxis
September 2017

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