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Information about Stereotaxis’ Clinical Trial – MAGNETIC-VT

 

Stereotaxis is conducting a study to determine if having a VT ablation using the Niobe® ES Remote Magnetic Navigation system is better than using manual techniques.  This site contains information about the current clinical study sponsored by Stereotaxis, Inc. and registered on www.clinicaltrials.gov.

In the Magnetic-VT Study, patients will be randomized (like flipping a coin) to have their VT ablation procedure performed by either remote magnetic navigation or  manual technique.  The physicians participating in this trial are experienced using both techniques, and both methods of doing this procedure as well as all of the equipment are approved by the FDA.  If you meet the following criteria, you will be considered to participate in the Magnetic-VT Study.

  1. 18 years of age or older
  2. Have an implantable cardioverter defibrillator (ICD implanted)
  3. Diagnosed with Monomorphic VT that does not respond well to medications
  4. Have had a previous heart attack
  5. Left Ventricle ejection fraction of < 35%
  6. You area a candidate for ischemic VT RF Ablation

If you are enrolled into the study, you will be required to be seen in follow-up to closely monitor your progress.  Visits include a 3, 6, 9, and 12-month visit which include having an EKG, physical exam, and a questionnaire on how you are feeling.  After the 1-year visit, you will have completed your requirements for the study.

If you or your physician have questions regarding this particular study that is currently enrolling subjects, please see the “Contact Information” listed below to discuss your qualifications for the Magnetic-VT study.

This information is not intended to replace the advice of your health care practitioner. Only your physician, in consultation with you, can diagnose your condition and decide whether this particular therapy is appropriate for you. We urge you to contact your physician if you have questions whether any therapy identified on this site may be appropriate for you. Please note that you will have to be evaluated by the study physician to determine whether you are eligible for the Magnetic-VT study.

Hospitals currently enrolling patients:

United States, Georgia
Augusta University (Augusta, GA, United States, 30912)
Contact: Julie Jordan, 1.706.721.0193, jujordan@gru.edu
Principal Investigator: Adam Berman, MD

United States, Illinois
University of Chicago Medical Center (Chicago, IL, United States, 60637)
Contact: Tiffany Hart, 1.773.702.0535, thart@medicine.bsd.uchicago.edu
Principal Investigator: Roderick Tung, MD

Advocate Christ Medical Center (Oak Lawn, IL, United States, 60453)
Contact: Michelle Nellett, 1.708.684.4522, michelle.nellett@advocatehealth.com
Principal Investigator: William Spear, MD

United States, New York
Weill Cornell Medical
 (New York, NY, United States, 10065)
Contact: Rosa A Chu, 1.212.746.4857, roc2025@med.cornell.edu
Principal Investigator: Jim W Cheung, MD     

United States, Kansas
The University of Kansas Medical Center (Kansas City, Kansas, United States, 66160)
Contact: Margana Morgan, 1.913.945.6443, mmorgan@kumc.edu
Principal Investigator: Dhanunjaya Lakkireddy, MD

United States, Texas
Texas Cardiac Arrhythmia Research Foundation (Austin, TX, United States, 78705)
Contact: Deb Cardinal, 1.512.458.9410, dscardinal@austinheartbeat.com
Principal Investigator: Andrea Natale, MD

United States, Utah
Intermountain Heart Institute (Murray, UT, United States, 84107)
Contact: Kevin Graves, 1.801.507.4754, Kevin.graves @imail.org
Principal Investigator: J. Peter Weiss, MD

Australia
Westmead Hospital (Westmead, New South Wales, Australia, 2145)
Contact: Patricia King, 61.2.8890.4719, patricia.king@health.nsw.gov.au
Principal Investigator: Pramesh Kovoor, MD, PhD

Belgium
AZ Sint-Jan (Brugge, West Flanders, Belgium, 8000)
Contact: Katrien Derycker, 32.50.45.38.96, katrien.derycker@azsintjan.be
Principal Investigator: Rene Tavernier, MD

ZNA Middelheim (Antwerpen, Belgium)
Contact:Marleen Bogaert, 32.3.280.32.09, marleen.bogaert@zna.be
Principal Investigator: Bruno Schwagten, MD

Czech Republic
Na Homolce Hospital (Roentgenova 2, 15030  Prague 5, Czech Republic)
Contact: Jitka Hofmanova, 420.257.272. 376, jitka.hofmanova@homolka.cz
Principal Investigator:Petr Neuzil, MD, PhD

Denmark
Rigshospitalet (Copenhagen, Denmark)
Contact: Aslaug Karlsdottir, 45.35.45.70.59, aslaug.thora.karlsdottir@regionh.dk
Principal Investigator: Xu Chen, MD

France
Chu De Nancy – Hôpitaux De Brabois
(Nancy, France)
Contact: Véronique Midenet, 33.383153881, v.midenet@chru-nancy.fr 
Principal Investigator: Christian De Chillou, MD/PhD

Netherlands
Erasmus Medical Center (Rotterdam, Netherlands)
Contact: Petter Janse, 31.10.703.5018, p.janse@erasmusmc.nl
Principal Investigator: Tamas Szili-Torok, MD

Onze Lieve Vrouwe Gasthuis (OLVG) (Amsterdam, Netherlands)
Contact: Rukiye Akpinar-Turan, r.turan@olvg.nl
Principal Investigator: Muchtiar Khan, MD

Access the MAGNETIC-VT trial on ClinicalTrials.gov (Identifier: NCT02637947)
https://clinicaltrials.gov/ct2/show/study/NCT02637947.

If you have general questions regarding Stereotaxis and remote magnetic navigation technology, we welcome you to Contact Us.

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