Stereotaxis Idiopathic Ventricular Tachycardia (VT) Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:3/30/2013
Start Date:March 2011
End Date:October 2012
Contact:Jennifer Bremer, RN
Email:jennifer.bremer@osumc.edu
Phone:6142477387

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RF Ablation of Idiopathic VT and PVCs Using Remote Magnetic Navigation


This study will assess the outcomes of using magnetic navigation to treat ventricular
tachycardia (VT) or premature ventricular contractions (PVCs) that occur for unknown reasons
and are not related to structural heart disease.


During conventional ventricular arrhythmia ablation procedures, simply contacting the
cardiac wall can significantly alter the electrocardiogram. Induction of ventricular ectopy
is important in determining the focus of the arrhythmogenic tissue during an
electrophysiology (EP) procedure; however, instrumentation with stiff ablation catheters can
temporarily eliminate VT during the mapping portion of the procedure making it difficult to
track the arrhythmia prior to ablating the tissue responsible for its genesis. The
catheters used with the Stereotaxis Magnetic Navigation System (MNS) are less stiff compared
to manual catheters since no pull wires are required to deflect the distal tip. Large
external magnets positioned on either side of the EP procedure table create a magnetic field
within the patient's chest. These large magnets (in direct relationship to the magnetic
field) can be manipulated using specialized software. The physician controls the distal tip
of the catheter by using the software while remotely using a catheter advancing system
(QuickCAS®, Stereotaxis, Inc, St. Louis, MO) to reach the desired location within the heart.
The soft catheters may provide a unique quality to the electrophysiologist who may assist
by providing accurate maps without temporarily eliminating the ventricular ectopy due to
excessive mechanical forces applied to the cardiac tissue. This study will assess the
physician's ability to appropriately map and ablate the ventricular substrate using remote
magnetic technology. All devices are approved by FDA and no off-label use of the products
is mandated within the protocol.

Inclusion Criteria:

- Patients must be between 18 - 80 years of age

- Willing to provide written informed consent

- Present with ventricular ectopy of non-ischemic origin

- able to be safely exposed to a static magnetic field

- Failure of at least 1 antiarrhythmic medication

Exclusion Criteria:

- Presence of a mobile ventricular thrombus

- Unable to obtain percutaneous access to the left ventricle

- Contraindicated for short-term anticoagulation therapy

- Life expectancy less than 1 year

- Body habitus limits placement on the procedure table

- Previously failed ablation procedure for VT/PVCs
We found this trial at
1
site
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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