Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia (STOP-VT)

This study has been completed.
Information provided by (Responsible Party):
Stereotaxis Identifier:
First received: February 24, 2009
Last updated: July 27, 2015
Last verified: July 2015

February 24, 2009
July 27, 2015
June 2009
October 2012   (final data collection date for primary outcome measure)
Percentage of Participants Free From VT at 1 Year Post-Treatment [ Time Frame: 1 Year follow-up ] [ Designated as safety issue: No ]
In order to qualify for inclusion in the chronic success statistic, patients must first be an acute success and must have had no VTs identified in their ICD history post ablation therapy.
Outcomes of the magnetic navigation system in VT cases [ Time Frame: 1 Year follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00851279 on Archive Site
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Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia
Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia: Data Collection of Clinical Scar-related VT Cases
This is a prospective, non-randomized, multi-center clinical case series evaluating the outcomes of the magnetic navigation system in ventricular tachycardia (VT) cases. Subjects will be evaluated acutely and will be followed clinically at 1, 6 and 12 months post-treatment.

Catheter ablation of ventricular tachycardia (VT) is greatly facilitated by using a substrate mapping approach - that is, mapping of the left ventricle during sinus or paced rhythm to identify diseased myocardium. Using three dimensional electroanatomical mapping, it is possible to reconstruct an anatomical rendering of the left ventricle based on voltage. For hemodynamically stable or unstable VTs, various electrophysiologic maneuvers can then be used to identify the critical portions of the VT circuit within the scar (entrainment mapping, identification of diastolic potentials, identification of electrically-unexcitable scar, fractionated potentials and pace mapping).

These methods are limited by the resolution of the substrate map, accuracy of catheter manipulation, and operator skill. To this end, a magnetic navigation system has been developed that allows for remote cardiac mapping. When used in concert with a compatible electroanatomical mapping system, it is possible to create a high-density ventricular substrate map of healed myocardial infarction. By removing the necessity for technical skill with catheter manipulation, this system has the potential for both improving the efficacy of VT ablation and expanding the clinical use of this substrate mapping approach.

Recently, a higher-powered, irrigated tip catheter has become available in certain markets for use in cardiac arrhythmia ablations. This study will evaluate the outcomes of using this magnetic irrigation ablation catheter during mapping and ablation of VT while also using remote magnetic navigation.

Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ventricular Tachycardia
Device: Magnetic irrigated ablation catheter
Magnetic irrigated catheter to be used with the magnetic navigation system
Other Names:
  • Niobe
  • Stereotaxis
  • Navigant
Experimental: Magnetic irrigated ablation catheter
Patients with documented VT and prior MI, in whom an ICD was implanted either for primary or secondary prevention, were recruited for endocardial mapping/ablation during VT (entrainment mapping, activation mapping) and/or substrate mapping in sinus rhythm (elimination of fractionated/late potentials, endocardial scar homogenization) with remote magnetic navigation (Niobe, Stereotaxis Inc.,St Louis, USA) and irrigated RF ablation (NaviStar RMT ThermoCool, Biosense Webster,California, USA).
Intervention: Device: Magnetic irrigated ablation catheter
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2013
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must be between the ages of 18 - 80 years
  • Willing to provide prior written informed consent per local ethics committee guidelines
  • Subjects must present with ventricular tachycardia, characterized by: history of myocardial scar and spontaneous ventricular tachycardia
  • Able to be safely exposed to static magnetic fields
  • No in-situ devices are present or any in-situ devices have been verified to be compatible to magnetic fields

Exclusion Criteria:

  • Presence of a mobile ventricular thrombus
  • Inability to access the left ventricle
  • Subjects must not have any contraindications to short-term anticoagulation
  • Subjects must not have a life expectancy of <1 year due to a medical illness
18 Years to 80 Years
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   Germany
Not Provided
Principal Investigator: Petr Neuzil, MD Na Homolce Hospital, Prague, CZ
July 2015

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