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

This study is currently recruiting participants.
Verified September 2017 by Stereotaxis
Sponsor:
ClinicalTrials.gov Identifier:
NCT02637947
First Posted: December 22, 2015
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Stereotaxis
  Purpose
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 Intervention
Tachycardia, Ventricular Device: catheter ablation using magnetic navigation Device: catheter ablation using manual navigation

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Stereotaxis:

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

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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


Estimated Enrollment: 386
Study Start Date: January 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Ken Lock 13146786123 ken.lock@stereotaxis.com

Locations
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Julie Jordan    706-721-0193    jujordan@gru.edu   
Principal Investigator: Adam Berman, MD         
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Linda Bond    773-702-2676    lbond@medicine.bsd.uchicago.edu   
Principal Investigator: Roderick Tung, MD         
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Michelle Nellett    708-684-4522    michelle.nellett@advocatehealth.com   
Contact: Christopher Blair    7086845137    christopher.blair@advocatehealth.com   
Principal Investigator: Erik Wissner, MD         
Sub-Investigator: William Spear, MD         
United States, Kansas
The University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Margana Morgan, B.S.    913-945-6443    mmorgan@kumc.edu   
Principal Investigator: Dhanunjaya Lakkireddy, M.D.         
United States, New York
Weill Cornell Medical Recruiting
New York, New York, United States, 10065
Contact: Rosa A Chu    212-746-4857    roc2025@med.cornell.edu   
Principal Investigator: Jim W Cheung, MD         
United States, Texas
Texas Cardiac Arrhythmia Research Foundation Recruiting
Austin, Texas, United States, 78705
Contact: Deb Cardinal    512-458-9410    dscardinal@austinheartbeat.com   
Principal Investigator: Andrea Natale, MD         
United States, Utah
Intermountain Heart Institute Recruiting
Murray, Utah, United States, 84107
Contact: Jesse Whitfield    801-507-4889    jesse.whitfield@imail.org   
Principal Investigator: J. Peter Weiss, MD         
Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Patricia King    (02) 8890 4719    mailto:patricia.king@health.nsw.gov.au   
Principal Investigator: Pramesh Kovoor, MD, PhD         
Belgium
AZ Sint-Jan Recruiting
Brugge, West Flanders, Belgium, 8000
Contact: Katrien Derycker    32 50 45 38 96    katrien.derycker@azsintjan.be   
Principal Investigator: Rene Tavernier, MD         
ZNA Middelheim Recruiting
Antwerpen, Belgium
Contact: Marleen Bogaert    +32 3 280 32 09    marleen.bogaert@zna.be   
Principal Investigator: Bruno Schwagten, MD         
Czechia
Na Homolce Hospital Recruiting
Praha, Czechia, 15030
Contact: Jitka Hofmanova    +420 257 272 376    Jitka.Hofmanova@homolka.cz   
Principal Investigator: Petr Neuzil, MD, PhD         
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Aslaug Karlsdottir    4535457059    aslaug.thora.karlsdottir@regionh.dk   
Principal Investigator: Xu Chen, M.D.         
France
Chu De Nancy - Hôpitaux De Brabois Recruiting
Nancy, France
Contact: Véronique Midenet    +33 383153881    v.midenet@chru-nancy.fr   
Principal Investigator: Christian De Chillou, MD/PhD         
Netherlands
Onze Lieve Vrouwe Gasthuis (OLVG) Recruiting
Amsterdam, Netherlands
Contact: Rukiye Akpinar-Turan       r.turan@olvg.nl   
Principal Investigator: Muchtiar Khan, MD         
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: Petter Janse    +31 10 7035018    p.janse@erasmusmc.nl   
Principal Investigator: Tamas Szili-Torok, MD         
Sponsors and Collaborators
Stereotaxis
Investigators
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
  More Information

Responsible Party: Stereotaxis
ClinicalTrials.gov Identifier: NCT02637947     History of Changes
Other Study ID Numbers: CLIN-021
First Submitted: December 4, 2015
First Posted: December 22, 2015
Last Update Posted: September 8, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes