Clinical trial NCT00851279: Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia
Official title: Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia: Data Collection of Clinical Scar-related VT Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ventricular Tachycardia
Keywords: arrhythmia
ventricular tachycardia
ablation
mapping
electrophysiology
Lead sponsor: Stereotaxis
Sponsor class: INDUSTRY
First posted: 2009-02-25
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Percentage of Participants Free From VT at 1 Year Post-Treatment
timeFrame: 1 Year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Krannert Institute of Cardiology
state: Indiana
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Prague
country: Czech Republic
facility: Na Homolce Hospital
city: Leipzig
country: Germany
facility: Herzzentrum Universitat Leipzig
Study officials:
affiliation: Na Homolce Hospital, Prague, CZ
name: Petr Neuzil, MD
role: PRINCIPAL_INVESTIGATOR
References: