Stereotaxis Idiopathic Ventricular Tachycardia (VT) Study
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ventricular Tachycardia |
Device: RF Ablation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | RF Ablation of Idiopathic VT and PVCs Using Remote Magnetic Navigation |
- Change in 24-hour Holter Monitor (number of extra ventricular beats) [ Time Frame: Change from Holter Monitor Pre-procedure vs. 6-Months Post-procedure ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Treatment
Ablation of VT/PVCs using a magnetic RF ablation catheter
|
Device: RF Ablation
Ablation of arrhythmogenic ventricular tissue
Other Names:
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients will be diagnosed with any ventricular tachycardia or symptomatic PVCs of non-ischemic origin.
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Stereotaxis |
| ClinicalTrials.gov Identifier: | NCT01401608 History of Changes |
| Other Study ID Numbers: | PM-CLIN-015 |
| Study First Received: | July 20, 2011 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Stereotaxis:
|
VT ventricular tachycardia ablation magnetic navigation robotic |
Additional relevant MeSH terms:
|
Tachycardia Tachycardia, Ventricular Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013