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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stereotaxis
ClinicalTrials.gov Identifier:
NCT00851279
First received: February 24, 2009
Last updated: April 10, 2013
Last verified: July 2012

February 24, 2009
April 10, 2013
June 2009
October 2012   (final data collection date for primary outcome measure)
Outcomes of the magnetic navigation system in VT cases [ Time Frame: 1 Year follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00851279 on ClinicalTrials.gov 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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ventricular Tachycardia
Device: Magnetic irrigated catheter for VT
Magnetic irrigated catheter to be used with the magnetic navigation system
Other Names:
  • Niobe
  • Stereotaxis
  • Navigant
Experimental: Magnetic irrigated ablation catheter
Intervention: Device: Magnetic irrigated catheter for VT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United States,   Czech Republic
 
NCT00851279
PM-CLIN-013
No
Stereotaxis
Stereotaxis
Not Provided
Principal Investigator: Petr Neuzil, MD Na Homolce Hospital, Prague, CZ
Stereotaxis
July 2012

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