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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 : Active, not recruiting
First Posted : December 22, 2015
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Stereotaxis

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.

Condition or disease Intervention/treatment Phase
Tachycardia, Ventricular Device: catheter ablation using magnetic navigation Device: catheter ablation using manual navigation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

Active Comparator: Manual navigation
Catheter ablation using manual navigation for ventricular tachycardia via a manually navigated Thermocool catheter, or equivalent catheter.
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.




Primary Outcome Measures :
  1. freedom from any VT in the overall cohort [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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

  2. freedom from VT in large scar subpopulation [ Time Frame: 12 months ]
  3. 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

  4. mortality rate [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Total number of appropriate ICD defibrillator shocks [ Time Frame: 12 months ]
  2. Total number of ICD applications of anti-tachycardia pacing [ Time Frame: 12 months ]
  3. Total procedure time (skin to skin) [ Time Frame: through end of acute procedure, an average of 3 hours ]
  4. Total fluoroscopy time [ Time Frame: through end of acute procedure, an average of 3 hours ]
  5. Total fluoroscopy dose [ Time Frame: through end of acute procedure, an average of 3 hours ]
  6. Total mapping time [ Time Frame: through end of acute procedure, an average of 3 hours ]
  7. Total ablation time [ Time Frame: through end of acute procedure, an average of 3 hours ]
  8. Total mapping points prior to ablation [ Time Frame: through end of acute procedure, an average of 3 hours ]
  9. Total ablation energy delivery [ Time Frame: through end of acute procedure, an average of 3 hours ]
    Watts X seconds / Total scar surface area

  10. Patient quality of life (SF-12) [ Time Frame: 12 months ]
    Medical Outcomes Study 12-item Short-Form Health Survey



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637947


Locations
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United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
United States, Georgia
Augusta University
Augusta, Georgia, United States, 30912
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
United States, Kansas
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, New York
Weill Cornell Medical
New York, New York, United States, 10065
United States, Texas
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
United States, Utah
Intermountain Heart Institute
Murray, Utah, United States, 84107
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Belgium
AZ Sint-Jan
Brugge, West Flanders, Belgium, 8000
ZNA Middelheim
Antwerpen, Belgium
Czechia
Na Homolce Hospital
Praha, Czechia, 15030
Denmark
Rigshospitalet
Copenhagen, Denmark
France
Chu De Nancy - Hôpitaux De Brabois
Nancy, France
Netherlands
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Sponsors and Collaborators
Stereotaxis
Investigators
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Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stereotaxis
ClinicalTrials.gov Identifier: NCT02637947    
Other Study ID Numbers: CLIN-021
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes