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Stereotaxis Idiopathic Ventricular Tachycardia (VT) Study

This study has suspended participant recruitment.
(Difficult to recruit eligible subjects)
Sponsor:
Information provided by (Responsible Party):
Stereotaxis
ClinicalTrials.gov Identifier:
NCT01401608
First received: July 20, 2011
Last updated: September 30, 2013
Last verified: September 2013

July 20, 2011
September 30, 2013
March 2011
October 2013   (final data collection date for primary outcome measure)
Change in 24-hour Holter Monitor (number of extra ventricular beats) [ Time Frame: Change from Holter Monitor Pre-procedure vs. 6-Months Post-procedure ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01401608 on ClinicalTrials.gov Archive Site
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Stereotaxis Idiopathic Ventricular Tachycardia (VT) Study
RF Ablation of Idiopathic VT and PVCs Using Remote Magnetic Navigation

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Patients will be diagnosed with any ventricular tachycardia or symptomatic PVCs of non-ischemic origin.

Ventricular Tachycardia
Device: RF Ablation
Ablation of arrhythmogenic ventricular tissue
Other Names:
  • ThermoCool
  • Niobe
  • Stereotaxis
Treatment
Ablation of VT/PVCs using a magnetic RF ablation catheter
Intervention: Device: RF Ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
20
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01401608
PM-CLIN-015
No
Stereotaxis
Stereotaxis
Not Provided
Principal Investigator: Raul Weiss, MD Ohio State University
Stereotaxis
September 2013

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