Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia

Ventricular Tachycardia Clinical Trial

— STOP-VT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851279
• Other study ID #: PM-CLIN-013
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2009
• Last updated: July 27, 2015
• Start date: June 2009
• Est. completion date: April 2013

Study information

• Verified date: July 2015
• Source: Stereotaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• Magnetic irrigated ablation catheter
Magnetic irrigated catheter to be used with the magnetic navigation system

Locations

Country	Name	City	State
Czech Republic	Na Homolce Hospital	Prague
Germany	Herzzentrum Universitat Leipzig	Leipzig
United States	Krannert Institute of Cardiology	Indianapolis	Indiana
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Stereotaxis

Countries where clinical trial is conducted

United States,  Czech Republic,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Free From VT at 1 Year Post-Treatment	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.	1 Year follow-up	No

External Links

•   Study Sponsor