Stereotaxis Idiopathic Ventricular Tachycardia (VT) Study

This study has suspended participant recruitment.
(Difficult to recruit eligible subjects)
Sponsor:
Information provided by (Responsible Party):
Stereotaxis
ClinicalTrials.gov Identifier:
NCT01401608
First received: July 20, 2011
Last updated: September 30, 2013
Last verified: September 2013
  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

Resource links provided by NLM:


Further study details as provided by Stereotaxis:

Primary Outcome Measures:
  • 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:
  • ThermoCool
  • Niobe
  • Stereotaxis

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
Study Population

Patients will be diagnosed with any ventricular tachycardia or symptomatic PVCs of non-ischemic origin.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401608

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Stereotaxis
Investigators
Principal Investigator: Raul Weiss, MD Ohio State University
  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: September 30, 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 October 19, 2014