Stereotaxis Idiopathic Ventricular Tachycardia (VT) Study

Ventricular Tachycardia Clinical Trial

Official title:

RF Ablation of Idiopathic VT and PVCs Using Remote Magnetic Navigation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01401608
• Other study ID #: PM-CLIN-015
• Status: Terminated
• Phase: N/A
• First received: July 20, 2011
• Last updated: May 18, 2015
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: May 2015
• Source: Stereotaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• RF Ablation
Ablation of arrhythmogenic ventricular tissue

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Stereotaxis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24-hour Holter Monitor (number of extra ventricular beats)	Use of the MNS in mapping and ablation of idiopathic VT will lead to a 75% reduction in the number of individual ventricular ectopic beats 6 months after the procedure. Extra ventricular beats will be counted using a 24-hour Holter monitor pre-procedure (obtained no more than 30 days prior to the procedure) compared to a 24-hour Holter monitor 6 months post-procedure.	Change from Holter Monitor Pre-procedure vs. 6-Months Post-procedure	No