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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Ventricular Tachycardia
 Device: Magnetic irrigated catheter for VT
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia: Data Collection of Clinical Scar-related VT Cases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stereotaxis:

Primary Outcome Measures:
  • Outcomes of the magnetic navigation system in VT cases [ Time Frame: 1 Year follow-up ] [ Designated as safety issue: No ]
Enrollment: 53
Study Start Date: June 2009
Study Completion Date: April 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnetic irrigated ablation catheter Device: Magnetic irrigated catheter for VT
Magnetic irrigated catheter to be used with the magnetic navigation system
Other Names:
  • Niobe
  • Stereotaxis
  • Navigant

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.

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851279

Locations
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
Czech Republic
Na Homolce Hospital
Prague, Czech Republic, 15630
Germany
Herzzentrum Universitat Leipzig
Leipzig, Germany, 04289
Sponsors and Collaborators
Stereotaxis
Investigators
Principal Investigator: Petr Neuzil, MD Na Homolce Hospital, Prague, CZ
  More Information

Additional Information:
Study Sponsor  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Stereotaxis
ClinicalTrials.gov Identifier: NCT00851279     History of Changes
Other Study ID Numbers: PM-CLIN-013
Study First Received: February 24, 2009
Last Updated: April 10, 2013
Health Authority: Czech Republic: Ethics Committee
United States: Institutional Review Board

Keywords provided by Stereotaxis:
arrhythmia
ventricular tachycardia
ablation
mapping
electrophysiology

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
 Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 25, 2015