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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00851279
Other study ID # PM-CLIN-013
Secondary ID
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


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
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