Ventricular Tachycardia Clinical Trial
Official title:
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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