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Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study (VERSATILE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stereotaxis
ClinicalTrials.gov Identifier:
NCT01656772
First received: July 30, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

This study will evaluate the use of a robotic device that is remotely controlled to maneuver a circular mapping catheter in the left atrium during Atrial Fibrillation (AF) ablation procedures.


Condition Intervention Phase
Atrial Fibrillation, Magnetic Navigation, Robotic Control, RMT ThermoCool Catheter
Device: Vdrive Lasso navigation
Procedure: Manual Lasso navigation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study

Resource links provided by NLM:


Further study details as provided by Stereotaxis:

Primary Outcome Measures:
  • Safety outcome to be assessed by comparing the rate of serious adverse events within 7 days of the procedure between both the control and the investigational device groups. [ Time Frame: Within 7 days of the procedure ] [ Designated as safety issue: Yes ]
    The Vdrive will allow physicians to manipulate compatible circular mapping catheters while maintaining a safety profile that is not inferior to manual circular catheter navigation.


Enrollment: 120
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Manual Lasso navigation
Use of conventional manual navigation techniques with the Lasso catheter
Procedure: Manual Lasso navigation
Manually maneuver a Lasso catheter
Experimental: Vdrive Lasso navigation
Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter
Device: Vdrive Lasso navigation
Remote robotic Lasso navigation

Detailed Description:

Key to the success of an electrophysiology procedure is the ability to accurately map, sense and pace the heart. Electrophysiology mapping catheters are available in a variety of shapes and electrode configurations. The majority of these catheters are manipulated manually by the physician. The Vdrive simplifies these manipulations by allowing an operator to mechanically advance, retract, rotate, deflect and maneuver a circular mapping catheter. The circular mapping catheter is not altered in structure, function or indication in the same manner as the predicate device (Cardiodrive Catheter Advancement System).

This is a prospective, randomized, non-blinded, controlled study comparing manual navigation of a circular mapping catheter with mechanical navigation by the Vdrive. A total of 120 patients are expected to complete the study: 80 patients in the Vdrive navigation arm and 40 patients in the manual navigation arm. Patients will be enrolled at a minimum of one site in the European Union where the product is currently marketed and the United States, where the Vdrive is considered to be investigational.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Left atrial AF ablation procedure requiring the use of a Lasso mapping catheter
  • Subject must be at least 18 years of age
  • Subject must be male, female of no childbearing potential, or a female that has a negative pregnancy test prior to randomization

Exclusion Criteria:

  • Unable to safely expose subject to a magnetic field
  • Prior AF ablation procedure
  • Patients with fewer than 4 PVs are excluded
  • Patients with persistent AF in whom early recurrence of AF following cardioversion would preclude completion of the pacing maneuvers described in the protocol or patients with other conditions that would similarly preclude completion of the pacing maneuvers
  • Contraindication to procedure or unable to return for follow-up
  • History of clotting disorder, bleeding abnormalities or contraindication to anticoagulation
  • Actively participating in other cardiac device trial(s)
  • Currently pregnant
  • Under 18 years of age
  • Prosthetic valves
  • Atrial abnormalities (thrombus, myxoma or baffle)
  • Other exclusions per the investigator
  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: NCT01656772

Locations
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Texas
Texas Cardiac Arrhythmia Institute
Austin, Texas, United States, 78705
Baylor Research Institute
Dallas, Texas, United States, 75204
Belgium
ZNA Campus Middelheim Lindendreef 1
Antwerpen, Belgium, 2020
Germany
IKFE HDZ GbmH
Bad Oeynhausen, Germany, 32545
Sponsors and Collaborators
Stereotaxis
Investigators
Study Director: Qun Sha, MD Stereotaxis Inc
  More Information

No publications provided

Responsible Party: Stereotaxis
ClinicalTrials.gov Identifier: NCT01656772     History of Changes
Other Study ID Numbers: CLIN-020
Study First Received: July 30, 2012
Last Updated: January 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014