Stereotaxis Idiopathic Ventricular Tachycardia (VT) Study

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. Read our disclaimer for details. Identifier: NCT01401608
Recruitment Status : Terminated (Difficult to recruit eligible subjects)
First Posted : July 25, 2011
Last Update Posted : May 20, 2015
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Brief Summary:
This study will assess the outcomes of using magnetic navigation to treat ventricular tachycardia (VT) or premature ventricular contractions (PVCs) that occur for unknown reasons and are not related to structural heart disease.

Condition or disease Intervention/treatment
Ventricular Tachycardia Device: RF Ablation

Detailed Description:
During conventional ventricular arrhythmia ablation procedures, simply contacting the cardiac wall can significantly alter the electrocardiogram. Induction of ventricular ectopy is important in determining the focus of the arrhythmogenic tissue during an electrophysiology (EP) procedure; however, instrumentation with stiff ablation catheters can temporarily eliminate VT during the mapping portion of the procedure making it difficult to track the arrhythmia prior to ablating the tissue responsible for its genesis. The catheters used with the Stereotaxis Magnetic Navigation System (MNS) are less stiff compared to manual catheters since no pull wires are required to deflect the distal tip. Large external magnets positioned on either side of the EP procedure table create a magnetic field within the patient's chest. These large magnets (in direct relationship to the magnetic field) can be manipulated using specialized software. The physician controls the distal tip of the catheter by using the software while remotely using a catheter advancing system (QuickCAS®, Stereotaxis, Inc, St. Louis, MO) to reach the desired location within the heart. The soft catheters may provide a unique quality to the electrophysiologist who may assist by providing accurate maps without temporarily eliminating the ventricular ectopy due to excessive mechanical forces applied to the cardiac tissue. This study will assess the physician's ability to appropriately map and ablate the ventricular substrate using remote magnetic technology. All devices are approved by FDA and no off-label use of the products is mandated within the protocol.

Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: RF Ablation of Idiopathic VT and PVCs Using Remote Magnetic Navigation
Study Start Date : March 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Ablation of VT/PVCs using a magnetic RF ablation catheter
Device: RF Ablation
Ablation of arrhythmogenic ventricular tissue
Other Names:
  • ThermoCool
  • Niobe
  • Stereotaxis

Primary Outcome Measures :
  1. Change in 24-hour Holter Monitor (number of extra ventricular beats) [ Time Frame: Change from Holter Monitor Pre-procedure vs. 6-Months Post-procedure ]
    Use of the MNS in mapping and ablation of idiopathic VT will lead to a 75% reduction in the number of individual ventricular ectopic beats 6 months after the procedure. Extra ventricular beats will be counted using a 24-hour Holter monitor pre-procedure (obtained no more than 30 days prior to the procedure) compared to a 24-hour Holter monitor 6 months post-procedure.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be diagnosed with any ventricular tachycardia or symptomatic PVCs of non-ischemic origin.

Inclusion Criteria:

  • Patients must be between 18 - 80 years of age
  • Willing to provide written informed consent
  • Present with ventricular ectopy of non-ischemic origin
  • able to be safely exposed to a static magnetic field
  • Failure of at least 1 antiarrhythmic medication

Exclusion Criteria:

  • Presence of a mobile ventricular thrombus
  • Unable to obtain percutaneous access to the left ventricle
  • Contraindicated for short-term anticoagulation therapy
  • Life expectancy less than 1 year
  • Body habitus limits placement on the procedure table
  • Previously failed ablation procedure for VT/PVCs

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 identifier (NCT number): NCT01401608

United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Principal Investigator: Raul Weiss, MD Ohio State University

Responsible Party: Stereotaxis Identifier: NCT01401608     History of Changes
Other Study ID Numbers: PM-CLIN-015
First Posted: July 25, 2011    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015

Keywords provided by Stereotaxis:
ventricular tachycardia
magnetic navigation

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