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Completed

NCT Number: NCT00851279

Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Na Homolce Hospital, Prague, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic irrigated ablation catheter

Device

Magnetic irrigated catheter to be used with the magnetic navigation system

Other names: Niobe, Stereotaxis, Navigant

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stereotaxis

Industry

Registry information

Official study title

Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia: Data Collection of Clinical Scar-related VT Cases

Acronym: STOP-VT

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Feb 25, 2009
Registry last updated
Aug 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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