Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia (STOP-VT)
|ClinicalTrials.gov Identifier: NCT00851279|
Recruitment Status : Completed
First Posted : February 25, 2009
Results First Posted : August 24, 2015
Last Update Posted : August 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Tachycardia||Device: Magnetic irrigated ablation catheter||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia: Data Collection of Clinical Scar-related VT Cases|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||April 2013|
U.S. FDA Resources
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).
Device: Magnetic irrigated ablation catheter
Magnetic irrigated catheter to be used with the magnetic navigation system
- Percentage of Participants Free From VT at 1 Year Post-Treatment [ Time Frame: 1 Year follow-up ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851279
|United States, Indiana|
|Krannert Institute of Cardiology|
|Indianapolis, Indiana, United States, 46202|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Na Homolce Hospital|
|Prague, Czech Republic, 15630|
|Herzzentrum Universitat Leipzig|
|Leipzig, Germany, 04289|
|Principal Investigator:||Petr Neuzil, MD||Na Homolce Hospital, Prague, CZ|