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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Ventricular Tachycardia	Device: Magnetic irrigated ablation catheter	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	53 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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

Arms and Interventions

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Arm

Intervention/treatment

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; Other Names: Niobe; Stereotaxis; Navigant

Outcome Measures

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Primary Outcome Measures :

1. 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Study Sponsor 

Responsible Party:	Stereotaxis
ClinicalTrials.gov Identifier:	NCT00851279 History of Changes
Other Study ID Numbers:	PM-CLIN-013
First Posted:	February 25, 2009
Results First Posted:	August 24, 2015
Last Update Posted:	August 24, 2015
Last Verified:	July 2015

Keywords provided by Stereotaxis:

arrhythmia; ventricular tachycardia; ablation; mapping; electrophysiology

Additional relevant MeSH terms:

Tachycardia; Tachycardia, Ventricular; Arrhythmias, Cardiac	Heart Diseases; Cardiovascular Diseases; Pathologic Processes