Stereotaxis Idiopathic Ventricular Tachycardia (VT) Study

NCT01401608 | Terminated

• 1 other identifier: PM-CLIN-015
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventricular Tachycardia

Keywords

VT; ventricular tachycardia; ablation; magnetic navigation; robotic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment

Ablation of VT/PVCs using a magnetic RF ablation catheter

Device: RF Ablation

Interventions

RF Ablation DEVICE

Ablation of arrhythmogenic ventricular tissue

Also known as: ThermoCool, Niobe, Stereotaxis

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stereotaxis: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raul Weiss, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 25, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

US (1)