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

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ClinicalTrials.gov Identifier: NCT00851279
Recruitment Status : Completed
First Posted : February 25, 2009
Results First Posted : August 24, 2015
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Stereotaxis

Tracking Information
First Submitted Date  ICMJE February 24, 2009
First Posted Date  ICMJE February 25, 2009
Results First Submitted Date  ICMJE December 2, 2013
Results First Posted Date  ICMJE August 24, 2015
Last Update Posted Date August 24, 2015
Study Start Date  ICMJE June 2009
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2009)
Outcomes of the magnetic navigation system in VT cases [ Time Frame: 1 Year follow-up ]
Change History Complete list of historical versions of study NCT00851279 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia
Official Title  ICMJE Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia: Data Collection of Clinical Scar-related VT Cases
Brief Summary 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ventricular Tachycardia
Intervention  ICMJE Device: Magnetic irrigated ablation catheter
Magnetic irrigated catheter to be used with the magnetic navigation system
Other Names:
  • Niobe
  • Stereotaxis
  • Navigant
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2011)
53
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2009)
100
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00851279
Other Study ID Numbers  ICMJE PM-CLIN-013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stereotaxis
Study Sponsor  ICMJE Stereotaxis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Petr Neuzil, MD Na Homolce Hospital, Prague, CZ
PRS Account Stereotaxis
Verification Date July 2015

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